SECURE FDI TEST KIT
FDA 510(k) clearance K813216 · decided 1981-12-17
Clearance details
- K-number
- K813216
- Device name
- SECURE FDI TEST KIT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-09
- Decision date
- 1981-12-17
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- JHG
- Device class
- 2
- Regulation number
- 862.1455
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| AMNIOSTAT-FLM-PG (K061549) | Irvine Scientific Sales Co., Inc. | 2006-10-18 |
| TDXR FETAL LUNG MATURITY (K871593) | Abbott Laboratories | 1987-07-20 |
| AMNIO STAT-FLM AGGLUTINATION TEST (K834616) | Hana Biologics, Inc. | 1984-05-25 |
| AMNISTAT-FLM (K822150) | Hana Biologics, Inc. | 1982-10-21 |
| HELENA FETAL-TEK 200 METHOD (K811588) | Helena Laboratories | 1981-06-25 |
| FETAL MATURITY TEST PROCEDURE (K790798) | Helena Laboratories | 1979-06-05 |
Recalls involving this device
No recalls on record reference this clearance.