Rep(Tm) Spe TEMP-30-16-8 Procedure, 3170,3171,3172
FDA 510(k) K913058 · Helena Laboratories
510(k) numberK913058
Submission
- Device name
- Rep(Tm) Spe TEMP-30-16-8 Procedure, 3170,3171,3172
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- July 10, 1991
- Decision date
- October 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEF – Electrophoretic, Protein Fractionation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1630
- Specialty
- Clinical Chemistry
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Questions and answers
When was Rep(Tm) Spe TEMP-30-16-8 Procedure, 3170,3171,3172 cleared by the FDA?
Rep(Tm) Spe TEMP-30-16-8 Procedure, 3170,3171,3172 (K913058) received a 510(k) decision of Substantially Equivalent on October 30, 1991, 112 days after the submission was received.
What is the product code of K913058?
The FDA product code is CEF – Electrophoretic, Protein Fractionation, a Class I (low risk) device regulated under 21 CFR 862.1630.