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510(k) K772344

DATA ACQUISITION & COLLATING SYS. by Gilford Instrument Laboratories, Inc. — Product Code JJE

K772344 is an FDA 510(k) premarket notification submitted by Gilford Instrument Laboratories, Inc. for the device "DATA ACQUISITION & COLLATING SYS.". The FDA issued a decision of Substantially Equivalent on January 31, 1978. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Gilford Instrument Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1978
Date Received
December 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

Other clearances by Gilford Instrument Laboratories, Inc.

  • K823233 — SBA 300 CLINICAL CHEMISTRY ANALYZER (November 29, 1982)
  • K821583 — AMES/GILFORD OPTIMATE CLIN. CHEM & THER (June 24, 1982)
  • K802609 — CHEMISTRY ANALYZER IMPACT 400 (November 26, 1980)
  • K801889 — MODEL 203S CLINICAL CHEMISTRY ANALYZER (September 26, 1980)
  • K800085 — SYSTEM 203 CHEMISTRY ANALYZER (February 13, 1980)
  • K792361 — SYSTEM 103 CHEMISTRY ANALYZER (December 27, 1979)
  • K792087 — MICROFLAME PHOTOMETER (November 13, 1979)
  • K791968 — EIA (ELISA) READER (October 17, 1979)
  • K790073 — ANALYZER, IMPACT 100 (February 22, 1979)
  • K790072 — ANALYZER, IMPACT 200 (February 22, 1979)

Other clearances for product code JJE

  • K183375 — Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, (February 12, 2019)
  • K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMIS (May 16, 2014)
  • K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK (May 15, 2014)
  • K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE ( (January 9, 2014)
  • K130276 — DIMENSION EXL WITH LM SYSTEM (March 22, 2013)
  • K113253 — ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGEN (May 17, 2012)
  • K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEM (November 22, 2011)
  • K110035 — INDIKO (June 28, 2011)
  • K073370 — TC MATRIX CLINICAL CHEMISTRY ANALYZER (May 8, 2008)
  • K063144 — VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (November 13, 2006)

FDA data resources