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510(k) K896410

CELLOGNOST SYPHILIS H by Behring Diagnostics, Inc. — Product Code GMT

K896410 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "CELLOGNOST SYPHILIS H". The FDA issued a decision of Substantially Equivalent on May 15, 1990. The device falls under product code GMT (Antigens, Ha, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1990
Date Received
November 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

Other clearances for product code GMT

  • K971502 — SERODIA TP-PA (November 13, 1997)
  • K911640 — OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (July 24, 1991)
  • K911266 — MODIFIED PK TP CONTROL (May 7, 1991)
  • K905038 — OLYMPUS PK-TP ABSORBENT KIT (May 6, 1991)
  • K893124 — OLYMPUS PK(TM) TP (November 17, 1989)
  • K791897 — BACTO-HATTS (November 13, 1979)
  • K791457 — AGGLUTINOTEST-SYPHILIS (September 24, 1979)
  • K760098 — REAGENT, VDRL (August 3, 1976)

FDA data resources