REFLOTRON HEMOGLOBIN TEST TABS
FDA 510(k) clearance K934064 · decided 1993-12-06
Clearance details
- K-number
- K934064
- Device name
- REFLOTRON HEMOGLOBIN TEST TABS
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-30
- Decision date
- 1993-12-06
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- KHG
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| HEMOSITE TEST SYSTEM (K973649) | Gds Technology, LLC | 1998-08-31 |
| ABBOTT VISION HEMOGLOBIN (MODIFICATION) (K953221) | Abbott Laboratories | 1995-09-29 |
| 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 |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |