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510(k) K884967

BACTIGEN(R) H. INFLUENZAE TYPE B by Armkel, LLC — Product Code GRP

K884967 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "BACTIGEN(R) H. INFLUENZAE TYPE B". The FDA issued a decision of Substantially Equivalent on February 7, 1989. The device falls under product code GRP (Antisera, All Types, H. Influenza), a Class II device regulated under 21 CFR 866.3300. Armkel, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1989
Date Received
November 30, 1988
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 Armkel, LLC

  • K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST (October 19, 2004)
  • K030258 — FIRST RESPONSE PREGNANCY TEST (February 25, 2003)
  • K023405 — TROJAN MINT TINGLE BRAND LATEX CONDOMS (December 16, 2002)
  • K013433 — TROJAN PASSION BERRY GEL (March 5, 2002)
  • K013614 — TROJAN CRYSTAL CLEAR LIQUID (February 1, 2002)
  • K001212 — TROJAN EXTRA LARGE LATEX CONDOM (May 9, 2000)
  • K000748 — TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT (April 6, 2000)
  • K992232 — FIRST RESPONSE 1-STEP PREGNANCY (December 21, 1999)
  • K973310 — TBD* ONE-STEP OVULATION PREDICTOR TEST (October 27, 1997)
  • K973352 — BRAND NAME *1-STEP PREGNANCY (October 27, 1997)

Other clearances for product code GRP

  • K854490 — IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES (December 27, 1985)
  • K831525 — H-FLU B ELISA TEST (September 29, 1983)
  • 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