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510(k) K863059

CALCIOMETER by J. D. Assoc. — Product Code CIA

K863059 is an FDA 510(k) premarket notification submitted by J. D. Assoc. for the device "CALCIOMETER". The FDA issued a decision of Substantially Equivalent on September 26, 1986. The device falls under product code CIA (Methylthymol Blue, Calcium), a Class II device regulated under 21 CFR 862.1145. J. D. Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1986
Date Received
August 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methylthymol Blue, Calcium
Device Class
Class II
Regulation Number
862.1145
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)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863102 — GLUCOMETER-E (November 24, 1986)
  • K863109 — FERROFAST (November 24, 1986)

Other clearances for product code CIA

  • K870369 — CALCIUM REAGENT-METHYL THYMOL BLUE METHOD (August 19, 1987)
  • K822898 — DSL 1600 (December 9, 1982)
  • K792396 — ELVI CALCIUM (December 6, 1979)
  • K771468 — MULTISTAT III CALCIUM TEST (September 12, 1977)

FDA data resources