ABBOTT VISION HEMOGLOBIN (MODIFICATION)
FDA 510(k) clearance K953221 · decided 1995-09-29
Clearance details
- K-number
- K953221
- Device name
- ABBOTT VISION HEMOGLOBIN (MODIFICATION)
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1995-06-19
- Decision date
- 1995-09-29
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- KHG
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| 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 |
| FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 (K880038) | Sigma Diagnostics, Inc. | 1988-04-21 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |