QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY
FDA 510(k) clearance K942276 · decided 1995-01-20
Clearance details
- K-number
- K942276
- Device name
- QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY
- Applicant
- Isolab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-05-10
- Decision date
- 1995-01-20
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- GIQ
- Device class
- 2
- Regulation number
- 864.7415
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Akron, OH, 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 |
|---|---|---|
| SICKLE-2000 (K955719) | Medicus Technologies, Inc. | 1996-08-14 |
| HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 (K874429) | Hf Scientific, Inc. | 1988-02-04 |
Recalls involving this device
No recalls on record reference this clearance.