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510(k) K831525

H-FLU B ELISA TEST by Seragen Diagnostics, Inc. — Product Code GRP

K831525 is an FDA 510(k) premarket notification submitted by Seragen Diagnostics, Inc. for the device "H-FLU B ELISA TEST". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code GRP (Antisera, All Types, H. Influenza), a Class II device regulated under 21 CFR 866.3300. Seragen Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
May 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, H. Influenza
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

Other clearances by Seragen Diagnostics, Inc.

  • K872148 — VIVID CHLAMYDIA(TM) (August 19, 1987)
  • K851663 — QUICK-COUNT HEMATOLOGY CONTROLS (July 23, 1985)
  • K852260 — QUICK-CHEM CALIBRATION SET (July 22, 1985)
  • K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN) (June 25, 1985)
  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 1985)
  • K850209 — QUICK-LYTE (February 27, 1985)
  • K844743 — SERATEST ENA(RNP/SM) DETERMINATION (February 4, 1985)
  • K842563 — SERATEST DNA DETERMINATION (October 25, 1984)
  • K841504 — QUICK-COUNT PLUS 2 (June 11, 1984)
  • K840793 — CK/MB IMMUNO-ISOENZYME CONTROL SERUM (April 13, 1984)

Other clearances for product code GRP

  • K884967 — BACTIGEN(R) H. INFLUENZAE TYPE B (February 7, 1989)
  • K854490 — IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES (December 27, 1985)
  • K823348 — H. INFLUENZA B ANTISERA FOR CIE (December 28, 1982)
  • K821266 — BBL DIRECTIGEN MENINGITIS TEST KIT (June 1, 1982)
  • K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (March 11, 1982)

FDA data resources