FTA-ABS BIOPAK— 510(k) K802276

Substantially Equivalent

Bioware Products

FDA 510(k) clearance K802276 for FTA-ABS BIOPAK, Substantially Equivalent on 1980-10-23. Applicant: Bioware Products. Device class: 2.

Clearance details

Applicant: Bioware Products
Product code: Code JWL
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1980-09-18
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWL

K831296 — POLYCHACO FIA-ABS TEST FOR SYPHILIS1983-07-26
K801959 — FTA-ABS TEST1980-10-23
K801928 — LAB-TEK FTA-ABS KIT1980-08-20

More clearances from Bioware Products

K810144 — ALK-PHOS BIOPAK GEL1981-02-02
K802299 — K/K (ASMA/ANA) UNIVERSAL BIOPAK1981-01-29
K802308 — T/K (ATA/AMA) UNIVERSAL BIOPAK1980-12-01

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