FETAL-TEK CONTROL MATURE— 510(k) K820319
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K820319 for FETAL-TEK CONTROL MATURE, Substantially Equivalent on 1982-03-25. Applicant: Helena Laboratories. Device class: 1.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JJS
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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