REPTILASE -PC— 510(k) K843207

Substantially Equivalent

Bio/Data Corp.

FDA 510(k) clearance K843207 for REPTILASE -PC, Substantially Equivalent on 1984-10-23. Applicant: Bio/Data Corp.. Device class: 2.

Clearance details

Applicant: Bio/Data Corp.
Product code: Code JCO
Device class: Class 2
Regulation: 21 CFR 864.8100
Advisory panel: Hematology
Date received: 1984-08-15
Decision date: 1984-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCO

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K852519 — DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE1985-08-12
K840210 — REPTILASE-R HA351984-04-23

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K881150 — KINETIC FIBRINOGEN ASSAY1988-03-28
K873382 — PLATELET EXTRACT REAGENT1987-11-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.