REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172— 510(k) K913058
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K913058 for REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172, Substantially Equivalent on 1991-10-30. Applicant: Helena Laboratories. Device class: 1.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CEF
- Device class
- Class 1
- Regulation
- 21 CFR 862.1630
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
Recent devices under product code CEF
view allMore clearances from Helena Laboratories
view all- K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL
- K100103 — SPECIALTY ASSAYED CONTROL-2
- K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
- K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
- K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Data sourced from openFDA. This site is unofficial and independent of the FDA.