ASSERACHROM PROTEIN C KIT
FDA 510(k) clearance K854016 · decided 1986-01-03
Clearance details
- K-number
- K854016
- Device name
- ASSERACHROM PROTEIN C KIT
- Applicant
- American Bioproducts Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-27
- Decision date
- 1986-01-03
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- JLA
- Device class
- 1
- Regulation number
- 862.1210
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch American Bioproducts Co.
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 |
|---|---|---|
| ERYTHOCYTE CREATINE (K852767) | Panmed, Inc. | 1986-11-13 |
Recalls involving this device
No recalls on record reference this clearance.