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510(k) K792337

DONNECT. DIAG. CALCIUM DIAG. REAGENT by Connecticut Diagnostics, Ltd. — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
November 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Connecticut Diagnostics, Ltd.

  • K905617 — VISI-STAPH (March 29, 1991)
  • K822501 — CDL ISOTONIC DILUENT (September 17, 1982)
  • K822500 — CDL LYSING REAGENT (September 17, 1982)
  • K822504 — CDL AUTO-LYSING REAGENT (September 17, 1982)
  • K811222 — INORGANIC PHOSPHORUS REAGENTS (May 21, 1981)
  • K801897 — GLUCOSE DIAGNOSTIC REAGENT (October 10, 1980)
  • K801898 — URIC ACID DIAGNOSTIC REAGENT (October 10, 1980)
  • K792465 — CONNECTICUT DIAGNOSTICS, LTS. DIRECT (December 18, 1979)
  • K792339 — CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN (December 6, 1979)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)

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