NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT
FDA 510(k) clearance K903995 · decided 1990-12-13
Clearance details
- K-number
- K903995
- Device name
- NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-29
- Decision date
- 1990-12-13
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- GHD
- Device class
- 1
- Regulation number
- 864.7660
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sigma Chemical 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 |
|---|---|---|
| NITRO BLUE TETRAZOLIUM REDUCTION (K904022) | Sigma Chemical Co. | 1990-12-18 |
| ALKALINE PHOSPHATASE, LEUKOCYTE, KIT (K896092) | Sigma Chemical Co. | 1989-11-09 |
| CHEMSTRIP L (K811189) | Biodynamics Corp. | 1981-07-27 |
Recalls involving this device
No recalls on record reference this clearance.