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510(k) K863112

PROTEINMETER by J. D. Assoc. — Product Code JGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1986
Date Received
August 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lowry (Colorimetric), Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type

Other clearances by J. D. Assoc.

  • K863103 — PEG 6,000 (January 13, 1987)
  • K863054 — AST S.C.E. (GOT) (January 13, 1987)
  • K863069 — MAGNESIOMETER (December 31, 1986)
  • K863079 — CREATINKINETIC (December 12, 1986)
  • K863068 — LDH S.C.E. (December 10, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863056 — BILIRUBIN TOTAL (November 24, 1986)
  • K863109 — FERROFAST (November 24, 1986)
  • K863102 — GLUCOMETER-E (November 24, 1986)

Other clearances for product code JGP

  • K070757 — MICROPROTEIN REAGENT SET (December 4, 2007)
  • K964960 — VITROS CHEMISTRY PRODUCTS UPRO SLIDES (February 18, 1997)
  • K821534 — HEMATOLOGY DATA MANAGEMENT SYS (June 10, 1982)
  • K792347 — MICRO LOWRY PROTEINTEST (December 6, 1979)