KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024— 510(k) K920927
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K920927 for KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024, Substantially Equivalent on 1992-06-19. Applicant: Helena Laboratories. Device class: 1.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.