510(k) K210069
- Device
- Minuteful - Kidney Test
- Applicant
- Healthy.io Ltd.
- 510(k) number
- K210069
- Product code
- JIR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-06
- Date received
- 2021-01-11
- Regulation
- 862.1645
- Classification name
- Indicator Method, Protein Or Albumin (urinary, Non-quant.)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ron Zohar
- Address
- 2 Ibn Gabirol St. Tel Aviv IL 6407702 6407702
FDA Registration Numbers#
- 8040374
- 3038206980
- 3003422726
- 3004192065
- 3011689956
- 3005841640
- 3009238284
- 3014150341
- 9615507
- 3042471840
- 2025099
- 3006198300
- 3013545943
- 3009448641
- 3013660430
- 9680746
- 3013298431
- 3002806944
- 1649661
- 3008987086
- 9710094
- 9610633
- 3002800697
- 1417592
- 1616487
- 3008058135
- 9611444
- 3034731501
- 4580
- 3007301207
- 2029372
- 9610126
- 2245285
- 3010564249
- 1219029
- 3003795116
- 1036362
- 3043127699
- 2244821
- 3010324880
- 1181121
- 3010891909
- 3008517993
- 1832816
- 3005360469
- 3015341499
- 3006621318
- 3002637618
- 1832216
- 3021186226
- 3007126977
- 3030446844
- 3012421607
- 3013679502
- 3015921024
- 3021841051
- 1419699
- 3024463179
- 3004493545
- 3006479639
- 3024171133
- 3012494290
- 9613069
- 3014255036
- 2122870
- 1061932
- 3004043187
- 3003917514
- 3031915160
- 2030633
- 3016712364
- 2531491
- 3003741796
- 2432235
Source Documents#
Other 510(k) Records For Product Code JIR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | 2023-09-08 |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | ACON Laboratories, Inc. | 2015-04-30 |
| K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS | Teco Diagnostics | 2007-01-26 |
| K022538 | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 | Diagnostic Chemicals, Ltd. (Usa) | 2002-08-23 |
| K001810 | URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING | Flexsite Diagnostics, Inc. | 2000-08-14 |
| K994035 | IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 | Diagnostic Chemicals , Ltd. | 2000-02-01 |
| K992257 | NEW MULTIPLES REAGENT STRIPS | Bayer Corp. | 1999-11-24 |
| K991315 | MICROALBUSTIX REAGENT STRIPS (OTC) | Bayer Corp. | 1999-11-12 |
| K983774 | UALB | Abbott Laboratories | 1999-01-28 |
| K972960 | HEALTH CHECK URI-TEST PROTEIN IN URINE | Tcpi, Inc. | 1998-10-07 |
| K982219 | MICROALBUSTIX REAGENT STRIPS | Bayer Corp. | 1998-08-12 |
| K972337 | DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA | Diagnostic Chemicals , Ltd. | 1997-08-08 |
| K970932 | ORGENTEC MICRO-ALBUMIN EIA ASSAY | American Laboratory Products Co., Ltd. | 1997-04-08 |
| K963142 | DCA 2000 + MICROALBUMIN/CREATININE ASSAY | Bayer Corp. | 1996-09-27 |
| K951222 | TOTAL PROTEIN (URINE) | Randox Laboratories, Ltd. | 1996-04-24 |
Legacy Summary#
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FDA Review#
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