TITAN GEL SERUM CONTROL— 510(k) K821982
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K821982 for TITAN GEL SERUM CONTROL, Substantially Equivalent on 1982-08-16. 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
- Mchenry, IL, US
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Recalls naming K821982
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K821982.
Data sourced from openFDA. This site is unofficial and independent of the FDA.