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510(k) K911266

MODIFIED PK TP CONTROL by Olympus Corp. — Product Code GMT

K911266 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "MODIFIED PK TP CONTROL". The FDA issued a decision of Substantially Equivalent on May 7, 1991. The device falls under product code GMT (Antigens, Ha, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1991
Date Received
March 15, 1991
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 Olympus Corp.

  • K915402 — EW-10 AND EW-20 (June 23, 1995)
  • K933200 — OLYMPUS PBD STENTS (April 5, 1995)
  • K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES (November 30, 1994)
  • K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (August 29, 1994)
  • K934835 — FLOVAL (June 21, 1994)
  • K931764 — HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES (June 8, 1994)
  • K915857 — FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (March 11, 1994)
  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
  • K934889 — OLYMPUS IMAGEMANAGER SYSTEM (January 28, 1994)
  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)

Other clearances for product code GMT

  • K971502 — SERODIA TP-PA (November 13, 1997)
  • K911640 — OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (July 24, 1991)
  • K905038 — OLYMPUS PK-TP ABSORBENT KIT (May 6, 1991)
  • K896410 — CELLOGNOST SYPHILIS H (May 15, 1990)
  • 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