Home / 510(k) Clearances / K792337

510(k) K792337

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

K792337 is an FDA 510(k) premarket notification submitted by Connecticut Diagnostics, Ltd. for the device "DONNECT. DIAG. CALCIUM DIAG. REAGENT". The FDA issued a decision of Substantially Equivalent on December 6, 1979. The device falls under product code CIC (Cresolphthalein Complexone, Calcium), a Class II device regulated under 21 CFR 862.1145. Connecticut Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.

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)
  • K822504 — CDL AUTO-LYSING REAGENT (September 17, 1982)
  • K822500 — CDL LYSING REAGENT (September 17, 1982)
  • K822501 — CDL ISOTONIC DILUENT (September 17, 1982)
  • K811222 — INORGANIC PHOSPHORUS REAGENTS (May 21, 1981)
  • K801898 — URIC ACID DIAGNOSTIC REAGENT (October 10, 1980)
  • K801897 — GLUCOSE DIAGNOSTIC REAGENT (October 10, 1980)
  • K792465 — CONNECTICUT DIAGNOSTICS, LTS. DIRECT (December 18, 1979)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)
  • K792340 — CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE (December 6, 1979)

Other clearances for product code CIC

  • K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (May 2, 2013)
  • K083339 — DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) (March 9, 2009)
  • K070249 — ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONT (April 26, 2007)
  • K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (March 24, 2006)
  • K050077 — SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS (February 15, 2005)
  • K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT (June 25, 2004)
  • K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (March 13, 2003)
  • K013652 — WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 (December 21, 2001)
  • K000375 — RANDOX CALCIUM (April 5, 2000)
  • K991111 — BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110 (May 25, 1999)

FDA data resources