FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
FDA 510(k) clearance K880038 · decided 1988-04-21
Clearance details
- K-number
- K880038
- Device name
- FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-05
- Decision date
- 1988-04-21
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- KHG
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AnemoCheck Home (K221508) | Sanguina, Inc. | 2023-09-29 |
| AnemoCheck (K163215) | Sanguina, LLC | 2017-09-13 |
| ANEMIAPRO SELF-SCREENER (K042379) | Biosafe Laboratories, Inc. | 2004-12-15 |
| STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 (K020138) | Gds Technology | 2002-02-11 |
| CARESIDE HEMOGLOBIN (K001462) | Careside, Inc. | 2000-08-21 |
| HEMOSITE TEST SYSTEM (K994073) | Gds Technology, LLC | 2000-01-14 |
| HEMOSITE TEST SYSTEM (K973649) | Gds Technology, LLC | 1998-08-31 |
| ABBOTT VISION HEMOGLOBIN (MODIFICATION) (K953221) | Abbott Laboratories | 1995-09-29 |
| REFLOTRON HEMOGLOBIN TEST TABS (K934064) | Boehringer Mannheim Corp. | 1993-12-06 |
| BIOTRACK HEMOGLOBIN TEST CARTRIDGE (K895101) | Biotrack, Inc. | 1989-10-10 |
| CLINISTAT HEMOGLOBIN REAGENT TEST (K885227) | Heraeus Kulzer, Inc. | 1989-02-24 |
| EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 (K872653) | Em Diagnostic Systems, Inc. | 1987-07-23 |
Recalls involving this device
No recalls on record reference this clearance.