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510(k) K863070

FAST MUCOPROTEINS by J. D. Assoc. — Product Code JQN

K863070 is an FDA 510(k) premarket notification submitted by J. D. Assoc. for the device "FAST MUCOPROTEINS". The FDA issued a decision of Substantially Equivalent on September 11, 1986. The device falls under product code JQN (Colorimetric, Mucopolysaccharides), a Class I device regulated under 21 CFR 862.1505. J. D. Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1986
Date Received
August 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric, Mucopolysaccharides
Device Class
Class I
Regulation Number
862.1505
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)
  • K863068 — LDH S.C.E. (December 10, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863056 — BILIRUBIN TOTAL (November 24, 1986)
  • K863109 — FERROFAST (November 24, 1986)

Other clearances for product code JQN

  • K792554 — ELVI MUCAPROTEINS (January 16, 1980)

FDA data resources