GAMMA FETAL BLEED SCREENING TEST
FDA 510(k) clearance K820647 · decided 1982-05-12
Clearance details
- K-number
- K820647
- Device name
- GAMMA FETAL BLEED SCREENING TEST
- Applicant
- Gamma Biologicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-09
- Decision date
- 1982-05-12
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- LIM
- Device class
- 2
- Regulation number
- 864.7455
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, 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 |
|---|---|---|
| FETAL D TECTION KIT (K980314) | Biopool Intl., Inc. | 1998-04-08 |
Recalls involving this device
No recalls on record reference this clearance.