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510(k) K875098

CIBA CORNING MODEL 644 by Ciba Corning Diagnostics Corp. — Product Code JXR

K875098 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "CIBA CORNING MODEL 644". The FDA issued a decision of Substantially Equivalent on March 3, 1988. The device falls under product code JXR (Atomic Absorption Spectrophotometer, General Use), a Class I device regulated under 21 CFR 862.2850. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1988
Date Received
December 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Atomic Absorption Spectrophotometer, General Use
Device Class
Class I
Regulation Number
862.2850
Review Panel
TX
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 JXR

  • K900828 — PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. (April 9, 1990)
  • K842752 — ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT (August 22, 1984)
  • K842496 — ICP/6500 INDUCTIVELY-COUPLED PLASMA- (August 10, 1984)
  • K830799 — INDUCTIVELY-COUPLED PLASMA SPECTROMETER (April 12, 1983)
  • K820320 — MODEL 3030 ATOMIC ABSORPTION SPECTRO- (March 1, 1982)
  • K810536 — ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB (March 17, 1981)
  • K792557 — SPECTROPHATOMETER MODELS 2280 & 2380AA (January 16, 1980)
  • K792146 — ATOMIC SPECTROSCOPY SYSTEM (November 30, 1979)
  • K791074 — MODEL MHS-20, ATOMIC ABSORPTION ACCESS (August 22, 1979)
  • K790795 — MODEL 4000, SPECTROPHOTOMETER (July 24, 1979)

FDA data resources