510(k) K001462
- Device
- CARESIDE HEMOGLOBIN
- Applicant
- CARESIDE, INC.
- 510(k) number
- K001462
- Product code
- KHG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-08-21
- Date received
- 2000-05-10
- Regulation
- 864.7500
- Classification name
- Whole Blood Hemoglobin Determination
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH B ASARCH
- Address
- 6100 Bristol Pkwy. Culver City CA US 90230 90230
FDA Registration Numbers#
- 1616487
- 1318354
- 3004838836
- 1827821
- 9610126
- 1825740
- 3006198300
- 3003795116
- 3013660430
Source Documents#
Other 510(k) Records For Product Code KHG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221508 | AnemoCheck Home | Sanguina, Inc. | 2023-09-29 |
| K163215 | AnemoCheck | Sanguina, LLC | 2017-09-13 |
| K042379 | ANEMIAPRO SELF-SCREENER | Biosafe Laboratories, Inc. | 2004-12-15 |
| K020138 | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 | Gds Technology | 2002-02-11 |
| K994073 | HEMOSITE TEST SYSTEM | Gds Technology, LLC | 2000-01-14 |
| K973649 | HEMOSITE TEST SYSTEM | Gds Technology, LLC | 1998-08-31 |
| K953221 | ABBOTT VISION HEMOGLOBIN (MODIFICATION) | Abbott Laboratories | 1995-09-29 |
| K934064 | REFLOTRON HEMOGLOBIN TEST TABS | Boehringer Mannheim Corp. | 1993-12-06 |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | Biotrack, Inc. | 1989-10-10 |
| K885227 | CLINISTAT HEMOGLOBIN REAGENT TEST | Heraeus Kulzer, Inc. | 1989-02-24 |
| K880038 | FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 | Sigma Diagnostics, Inc. | 1988-04-21 |
| K872653 | EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 | Em Diagnostic Systems, Inc. | 1987-07-23 |
| K870363 | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD | Trace Scientific , Ltd. | 1987-03-16 |
| K863104 | TOTAL HEMOGLOBIN | J. D. Assoc. | 1986-09-04 |
| K862641 | U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) | U. S. Diagnostics, Inc. | 1986-08-21 |
Legacy Summary#
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FDA Review#
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