HEMOGLOBIN ANALYZER & PERFORM. CHECK SET
FDA 510(k) clearance K771101 · decided 1977-07-21
Clearance details
- K-number
- K771101
- Device name
- HEMOGLOBIN ANALYZER & PERFORM. CHECK SET
- Applicant
- The Dow Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-06-20
- Decision date
- 1977-07-21
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- GIG
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| RANDOX BILIRUBIN (K973995) | Randox Laboratories, Ltd. | 1997-12-08 |
| HBM HEMOGLOBINOMETER (K933836) | Artel, Inc. | 1994-03-31 |
Recalls involving this device
No recalls on record reference this clearance.