BACTON TM, BASIC TM, APO A-I REAGENT
FDA 510(k) clearance K893885 · decided 1989-06-21
Clearance details
- K-number
- K893885
- Device name
- BACTON TM, BASIC TM, APO A-I REAGENT
- Applicant
- Catachem, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-30
- Decision date
- 1989-06-21
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- DEL
- Device class
- 1
- Regulation number
- 866.5590
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Bridgeport, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Catachem
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (K013278) | Roche Diagnostics Corp. | 2001-11-15 |
| APOLIPOPROTEIN A-I (APO A-I) (K901675) | Sigma Chemical Co. | 1990-04-26 |
| APOLIPOPROTEIN B (APO B) (K900124) | Sigma Chemical Co. | 1990-03-02 |
| ORTHO *APO A-1 ELISA TEST SYSTEM (K895160) | Medical Marketing Consultants, Inc. | 1989-10-06 |
Recalls involving this device
No recalls on record reference this clearance.