H-FLU B ELISA TEST— 510(k) K831525

Substantially Equivalent

Seragen Diagnostics, Inc.

FDA 510(k) clearance K831525 for H-FLU B ELISA TEST, Substantially Equivalent on 1983-09-29. Applicant: Seragen Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Seragen Diagnostics, Inc.
Product code: Code GRP
Device class: Class 2
Regulation: 21 CFR 866.3300
Advisory panel: Microbiology
Date received: 1983-05-12
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GRP

K884967 — BACTIGEN(R) H. INFLUENZAE TYPE B1989-02-07
K854490 — IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES1985-12-27
K823348 — H. INFLUENZA B ANTISERA FOR CIE1982-12-28
K821266 — BBL DIRECTIGEN MENINGITIS TEST KIT1982-06-01
K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM1982-03-11

More clearances from Seragen Diagnostics, Inc.

K872148 — VIVID CHLAMYDIA(TM)1987-08-19
K851663 — QUICK-COUNT HEMATOLOGY CONTROLS1985-07-23
K852260 — QUICK-CHEM CALIBRATION SET1985-07-22
K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN)1985-06-25
K851521 — LD-1(IMMUNO) SEPARATION SET1985-05-10

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