This page includes the latest FDA filings for Simple Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Simple Diagnostics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3007384659 |
| FEI Number | 3007384659 |
| Name | SIMPLE DIAGNOSTICS |
| Owner & Operator | Simple Diagnostics, Inc. |
| Contact Address | 11555 HERON BAY BLVD. Suite 200 Coral Springs FL 33076 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 11555 Heron Bay Blvd. Suite 200 Coral Springs, FL 33076 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| Simple Diagnostics | Otc Medication | 2024-01-19 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0140-69 | 2023-02-22 |
| Simple Diagnostics | Otc Medication | 2022-11-24 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ Safety Lancet 98302-0140-20 | 2022-10-27 |
| SIMPLE DIAGNOSTICS INC | Pharmacist Choice 50002-0860-60 | 2022-10-27 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0140-12 | 2022-06-15 |
| SIMPLE DIAGNOSTICS INC | Clever Choice | 2022-06-10 |
| SIMPLE DIAGNOSTICS INC | Clever Choice | 2022-06-10 |
| Simple Diagnostics | Otc Medication | 2022-01-20 |
| SIMPLE DIAGNOSTICS INC | Clever Choice | 2022-01-12 |
| SIMPLE DIAGNOSTICS INC | Clever Choice | 2021-11-10 |
| SIMPLE DIAGNOSTICS INC | Clever Choice BSX231 | 2021-09-08 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0140-07 | 2021-01-13 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0140-09 | 2021-01-13 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0140-08 | 2021-01-13 |
| SIMPLE DIAGNOSTICS INC | Clever Choice CLT-186 | 2020-12-04 |
| SIMPLE DIAGNOSTICS INC | Clever Choice CLETEF-786 | 2020-12-04 |
| SIMPLE DIAGNOSTICS INC | Pharmacist Choice | 2020-09-09 |
| SIMPLE DIAGNOSTICS INC | Pharmacist Choice 98302-0001-60 | 2020-09-09 |
| SIMPLE DIAGNOSTICS INC | Pharmacist Choice 98302-0001-04 | 2020-09-09 |
| SIMPLE DIAGNOSTICS INC | Simple Diagnostics 98302-0001-00 | 2020-09-09 |
| SIMPLE DIAGNOSTICS INC | Pharmacist Choice | 2020-09-09 |
| SIMPLE DIAGNOSTICS INC | Clever Choice CLETEF-786 | 2020-09-08 |
| SIMPLE DIAGNOSTICS INC | Pharmacist Choice 62379-005-06 | 2020-08-07 |
| Simple Diagnostics, Inc. | Otc Medication | 2020-06-05 |
| Simple Diagnostics, Inc. | Clever Choice HAND SANITIZER | 2020-06-04 |
| Simple Diagnostics | Otc Medication | 2020-01-25 |
| Simple Diagnostics | Otc Medication | 2020-01-18 |
| SIMPLE DIAGNOSTICS INC | Clever Choice Peak Flow Meter 50002-0860-38 | 2019-11-12 |
| SIMPLE DIAGNOSTICS INC | Clever Choice | 2019-11-08 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0148-13 | 2019-11-08 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0148-12 | 2019-11-08 |
| SIMPLE DIAGNOSTICS INC | Clever Choice SDI-2086WT | 2019-11-08 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0001-30 | 2019-11-08 |
| SIMPLE DIAGNOSTICS INC | Clever Choice | 2019-11-01 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 62850-0000-25 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-20 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-19 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-18 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-17 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-16 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-15 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-14 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-12 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-11 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-10 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-09 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-08 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-07 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-06 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-05 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-04 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-03 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Pharmacist Choice 62850-0000-01 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Vet's Choice V31556 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Clever Choice | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-24 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-23 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-21 | 2019-10-10 |
| SIMPLE DIAGNOSTICS INC | Pharmacist's Choice 62850-0000-22 | 2019-10-09 |
| SIMPLE DIAGNOSTICS INC | Clever Choice | 2019-10-07 |
| SIMPLE DIAGNOSTICS INC | Vet's Choice V31556 | 2019-06-24 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0001-94 | 2019-04-10 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0001-93 | 2019-04-10 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0001-91 | 2019-04-02 |
| SIMPLE DIAGNOSTICS INC | Clever Choice 98302-0001-90 | 2019-04-02 |
| SIMPLE DIAGNOSTICS INC | Clever Choice | 2018-12-31 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-24 | 2018-11-16 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-23 | 2018-11-16 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-21 | 2018-11-16 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-20 | 2018-11-16 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-19 | 2018-11-16 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-18 | 2018-11-16 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-17 | 2018-11-16 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-16 | 2018-11-16 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-15 | 2018-11-16 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-14 | 2018-11-16 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-12 | 2018-11-12 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-11 | 2018-11-12 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-10 | 2018-11-12 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-09 | 2018-11-12 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-08 | 2018-11-12 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-07 | 2018-11-12 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-06 | 2018-11-12 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-05 | 2018-11-12 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-04 | 2018-11-12 |
| SIMPLE DIAGNOSTICS INC | Comfort EZ 62850-0000-03 | 2018-11-12 |
| SIMPLE DIAGNOSTICS INC | Pharmacist Choice 62850-0000-01 | 2018-11-09 |
| SIMPLE DIAGNOSTICS INC | Pharmacist's Choice 62850-0000-22 | 2018-03-29 |
| Simple Diagnostics | Otc Medication | 2017-10-10 |
| Simple Diagnostics. Inc. | Otc Medication | 2016-07-15 |
| Simple Diagnostics, Inc. | Otc Medication | 2015-02-24 |
| Simple Diagnostics. Inc. | PHARMACIST CHOICE ALCOHOL STERILE PREP PAD | 2015-02-23 |
| Simple Diagnostics, Inc. | Cold Hot Patch | 2015-02-23 |
SIMPLE DIAGNOSTICS, INC. | COMFORT EZ | 2012-12-06 |
SIMPLE DIAGNOSTICS, INC. | CLEVER CHOICE | 2012-08-21 |
SIMPLE DIAGNOSTICS, INC. | COMFORT EZ | 2012-08-10 |
| NCAGE Code | 6NX28 | SIMPLE DIAGNOSTICS INC |
| CAGE Code | 6NX28 | SIMPLE DIAGNOSTICS INC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2019082613899 | 57037 -> New York/Newark Area, Newark, New Jersey | INSULIN PEN NEEDLES | 8660 CTN |
| 2019082613899 | 57037 -> New York/Newark Area, Newark, New Jersey | INSULIN PEN NEEDLES INSULIN PEN NEEDLES INSULIN SYRINGE 510K# K121632 DEVICE LISTING # D254220 FDA PRODUCTS CODE FMI 510K# K122787 | 8660 CTN |
| 2019082613904 | 57037 -> New York/Newark Area, Newark, New Jersey | BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR SDI-1886AT BLOOD PRESSURE MONITOR SDI-1486A BLOOD PRESSURE MONITOR SDI-1586W | 496 CTN |
| 201908088865 | 57037 -> New York/Newark Area, Newark, New Jersey | INSULIN PEN NEEDLES | 7443 CTN |
| 201908088865 | 57037 -> New York/Newark Area, Newark, New Jersey | INSULIN PEN NEEDLES INSULIN PEN NEEDLES INSULIN SYRINGE 510K# K121632 DEVICE LISTING # D254220 FDA PRODUCTS CODE FMI 510K# K122787 | 7443 CTN |
| 2019071321388 | 57037 -> New York/Newark Area, Newark, New Jersey | INSULIN PEN NEEDLES 510K#:K121632 DEVICELI STING#:D254220 FDAPRODUCTSCODE:FMI | 36 PKG |
| 201906228234 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | PREP PADS PREP PADS SHIPPER MORE TEL 0086-10-61678701 FAX 0086-10-61678702 | 4005 CTN |
| 2019061514425 | Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey | HUMIDIFIER HUMIDIFIER | 50 CTN |
| 201905308902 | Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey | CLEVER CHOICE WHISPER AIRE COMPRESSOR NEBULI ZER (MCN-S600MK) | 240 CTN |
| 2019051714563 | 57037 -> New York/Newark Area, Newark, New Jersey | PVC HEATING PAD | 501 PKG |