GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
FDA 510(k) clearance K090846 · decided 2009-09-03
Clearance details
- K-number
- K090846
- Device name
- GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
- Applicant
- Perkinelmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-30
- Decision date
- 2009-09-03
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- JLW
- Device class
- 2
- Regulation number
- 862.1690
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitr recall (Z-1107-2017) | PerkinElmer Life and Analytical Sciences, Wallac, OY | 2017-01-27 |
| Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The recall (Z-2121-2012) | Perkinelmer | 2012-08-01 |
| Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for recall (Z-1116-2012) | PerkinElmer Life and Analytical Sciences, Wallac, OY | 2012-02-28 |
| The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high thro recall (Z-0603-2012) | PerkinElmer LAS, Inc | 2012-01-11 |