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510(k) K811222

INORGANIC PHOSPHORUS REAGENTS by Connecticut Diagnostics, Ltd. — Product Code CED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1981
Date Received
May 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
Device Class
Class I
Regulation Number
862.1520
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)
  • K822501 — CDL ISOTONIC DILUENT (September 17, 1982)
  • K822500 — CDL LYSING REAGENT (September 17, 1982)
  • K801898 — URIC ACID DIAGNOSTIC REAGENT (October 10, 1980)
  • K801897 — GLUCOSE 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)
  • K792340 — CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE (December 6, 1979)

Other clearances for product code CED

  • K894288 — PHOSPHORUS TEST ITEM NUMBER 65416 (August 31, 1989)
  • K840151 — EKTACHEM CLINICAL CHEM. SLIDES (March 22, 1984)
  • K833710 — BTC URINE LH ASSAY (January 30, 1984)
  • K820832 — PHOSPHORUS IL (April 15, 1982)
  • K812670 — SANDARE FAST 340 PHOSPHORUS PROCEDURE (October 2, 1981)
  • K811864 — SIGMA PROCEDURE 265-UV (July 31, 1981)
  • K802420 — CENTRIFICHEM INORGANIC PHOSPHORUS (October 31, 1980)
  • K790662 — CENTRIFICHEM INORGANIC PHOSPHORUS (May 15, 1979)