NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
FDA 510(k) clearance K021541 · decided 2002-10-28
Clearance details
- K-number
- K021541
- Device name
- NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
- Applicant
- Perkinelmer Life Sciences
- Decision
- Substantially Equivalent
- Date received
- 2002-05-10
- Decision date
- 2002-10-28
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- JNB
- Device class
- 2
- Regulation number
- 862.1555
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Norton, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0 recall (Z-0686-2013) | Perkinelmer | 2013-01-16 |