GSP NEONATALGALT KIT, MODEL 3303-001U
FDA 510(k) clearance K100101 · decided 2010-06-11
Clearance details
- K-number
- K100101
- Device name
- GSP NEONATALGALT KIT, MODEL 3303-001U
- Applicant
- Perkinelmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-01-13
- Decision date
- 2010-06-11
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- KQP
- Device class
- 2
- Regulation number
- 862.1315
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (K970277) | Astoria-Pacific, Inc. | 1997-12-11 |
| TOTAL GALACTOSE (K894011) | Alpkem Corp. | 1990-01-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in F recall (Z-2713-2026) | WALLAC OY | 2026-07-09 |