PHOSPHOLIPID REAGENT SET
FDA 510(k) clearance K914040 · decided 1991-10-30
Clearance details
- K-number
- K914040
- Device name
- PHOSPHOLIPID REAGENT SET
- Applicant
- Sterling Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-10
- Decision date
- 1991-10-30
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- JNT
- Device class
- 1
- Regulation number
- 862.1575
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sterling Heights, MI, 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 |
|---|---|---|
| ZITHROMAX (K922792) | Difco Laboratories, Inc. | 1992-07-30 |
| SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. (K792349) | Pfizer, Inc. | 1980-03-12 |
Recalls involving this device
No recalls on record reference this clearance.