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510(k) K823348

H. INFLUENZA B ANTISERA FOR CIE by Diagnostica, Inc. — Product Code GRP

K823348 is an FDA 510(k) premarket notification submitted by Diagnostica, Inc. for the device "H. INFLUENZA B ANTISERA FOR CIE". The FDA issued a decision of Substantially Equivalent on December 28, 1982. The device falls under product code GRP (Antisera, All Types, H. Influenza), a Class II device regulated under 21 CFR 866.3300. Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1982
Date Received
November 9, 1982
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 Diagnostica, Inc.

  • K002756 — EASE-A-CULT (February 23, 2001)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K800398 — PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT (March 12, 1980)
  • K791283 — ANTI-HUMAN LAMBDA SERUM (November 27, 1979)
  • K791284 — ANTI-HUMAN KAPPA SERUM (November 27, 1979)
  • K791281 — ANTI-HUMAN IGG SERUM (November 27, 1979)
  • K791285 — ANTI-HUMAN GLOBULINS (October 17, 1979)
  • K791282 — ANTI-HUMAN SERUM (October 17, 1979)
  • K790671 — DERMATOPHYTIN O (May 31, 1979)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 1979)

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)
  • K831525 — H-FLU B ELISA TEST (September 29, 1983)
  • K821266 — BBL DIRECTIGEN MENINGITIS TEST KIT (June 1, 1982)
  • K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (March 11, 1982)

FDA data resources