NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
FDA 510(k) clearance DEN040002 · decided 2004-08-24
Clearance details
- K-number
- DEN040002
- Device name
- NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
- Applicant
- Perkinelmer Life Sciences, Inc.
- Decision
- Unknown
- Date received
- 2004-07-02
- Decision date
- 2004-08-24
- Days to decision
- 53 days
- Clearance type
- Post-NSE
- Product code
- NQL
- Device class
- 2
- Regulation number
- 862.1055
- 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
No recalls on record reference this clearance.