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510(k) K894617

OLYMPUS PK-TP SYSTEM REACTIVE CONTROL by Schiff & Co. — Product Code GMI

K894617 is an FDA 510(k) premarket notification submitted by Schiff & Co. for the device "OLYMPUS PK-TP SYSTEM REACTIVE CONTROL". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code GMI (Antigen, Cf And / Or Id, Coccidioides Immitis), a Class II device regulated under 21 CFR 866.3135. Schiff & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf And / Or Id, Coccidioides Immitis
Device Class
Class II
Regulation Number
866.3135
Review Panel
MI
Submission Type

Other clearances by Schiff & Co.

  • K990511 — X-TIP INTRAOSSEOUS PERFORATOR (April 27, 1999)
  • K982136 — JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 (March 24, 1999)
  • K981629 — NUTRISAFE ENTERAL FEEDING TUBE (February 4, 1999)
  • K981630 — VYGON DOUBLE LUMEN UMBILICAL CATHETER (October 1, 1998)
  • K974141 — PLUS REUSABLE RESUSCITATOR (May 21, 1998)
  • K954448 — VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM (October 28, 1996)
  • K955085 — HM-CAP EIA TEST (MODIFICATION) (February 9, 1996)
  • K944159 — HM-CAP EIA KIT (July 18, 1995)
  • K943521 — VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE (February 14, 1995)
  • K896684 — KEMBLE LIQUID HANDLING SYSTEM DISPENSER (April 16, 1990)

Other clearances for product code GMI

  • K812190 — COCCIDIOIDES IMMUNODIFFUSION SYSTEM (August 31, 1981)
  • K812185 — FUNGAL IMMUNODIFFUSION SYSTEM (August 25, 1981)
  • K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL (September 26, 1980)
  • K792716 — CANDIDA ALBICANS, ANTIGEN (January 24, 1980)
  • K792713 — CANDIDA ALBICANS, ANTISERUM (January 23, 1980)
  • K792682 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K792689 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K791389 — COCCIDIOIDES ANTIGEN #CF10023X (August 16, 1979)
  • K791383 — CANDIDA IMMUNODIFFUSION KIT #CA1001 (August 16, 1979)
  • K770527 — CANDIDA IMMUNODIFFUSION KIT (March 17, 1978)

FDA data resources