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510(k) K872888

CIBA CORNING 288 PH/BLOOD GAS SYSTEM by Ciba Corning Diagnostics Corp. — Product Code JQY

K872888 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "CIBA CORNING 288 PH/BLOOD GAS SYSTEM". The FDA issued a decision of Substantially Equivalent on August 25, 1987. The device falls under product code JQY (Ph Meter), a Class I device regulated under 21 CFR 862.2050. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1987
Date Received
July 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Meter
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Ciba Corning Diagnostics Corp.

  • K962559 — ACS CORTISOL IMMUNOASSAY (November 5, 1996)
  • K963251 — CIBA CORNING ACS;180 DPD ASSAY (October 15, 1996)
  • K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (July 26, 1996)
  • K961657 — CIBA CORNING 400 SYSTEM (June 25, 1996)
  • K962021 — CIBA CORNING 348 SYSTEM (June 24, 1996)
  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
  • K962041 — ACS LH2 IMMUNOASSAY (June 21, 1996)
  • K961510 — ACS FRT4 IMMUNOASSAY (June 17, 1996)
  • K960246 — LIQUID CARDIAC MARKER 1,2,3 ASSAYED (April 23, 1996)
  • K955873 — ACS PHENYTOIN ASSAY (March 11, 1996)

Other clearances for product code JQY

  • K952178 — PH-DETECT TEST (October 20, 1995)
  • K905146 — OLYMPUS URINE PH (February 4, 1991)
  • K770347 — METER, PH, DIGITAL, MODEL 3560 (April 15, 1977)
  • K770352 — METER, IV PH, MODEL EXPANDOMATIC (April 8, 1977)
  • K770351 — METER, IV PH, MODEL ZEROMATIC (April 5, 1977)
  • K760789 — PH METER-130 (.001 PH) (November 16, 1976)
  • K760788 — PH METER-125 (.01 PH) (November 16, 1976)

FDA data resources