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510(k) K863112

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

K863112 is an FDA 510(k) premarket notification submitted by J. D. Assoc. for the device "PROTEINMETER". The FDA issued a decision of Substantially Equivalent on December 10, 1986. The device falls under product code JGP (Lowry (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. J. D. Assoc. has at least 10 other 510(k) clearances on record.

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.

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

FDA data resources