FETAL D TECTION KIT
FDA 510(k) clearance K980314 · decided 1998-04-08
Clearance details
- K-number
- K980314
- Device name
- FETAL D TECTION KIT
- Applicant
- Biopool Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-27
- Decision date
- 1998-04-08
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- LIM
- Device class
- 2
- Regulation number
- 864.7455
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- West Chester, PA, 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 |
|---|---|---|
| GAMMA FETAL BLEED SCREENING TEST (K820647) | Gamma Biologicals, Inc. | 1982-05-12 |
Recalls involving this device
No recalls on record reference this clearance.