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510(k) K884965

BACTIGEN(R) MENINGITIDIS PANEL by Armkel, LLC — Product Code GWC

K884965 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "BACTIGEN(R) MENINGITIDIS PANEL". The FDA issued a decision of Substantially Equivalent on February 7, 1989. The device falls under product code GWC (Antisera, All Types, Streptococcus Pneumoniae), a Class I device regulated under 21 CFR 866.3740. 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, Streptococcus Pneumoniae
Device Class
Class I
Regulation Number
866.3740
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 GWC

  • K884966 — BACTIGEN(R) S. PNEUMONIAE (February 7, 1989)
  • K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (March 25, 1987)
  • K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (December 18, 1986)
  • K842239 — VENTRESCREEN STREP A TEST (July 2, 1984)
  • K841376 — WELLCOGEN S. PNEUMONIAE (May 2, 1984)
  • K831887 — BACTIGEN S. PNEUMONIAE (September 26, 1983)
  • K821960 — BBL PNEUMOSLIDE TEST (July 30, 1982)
  • K802337 — PHADEBACT PNEUMOCOCCUS TEST (October 31, 1980)

FDA data resources