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510(k) K822500

CDL LYSING REAGENT by Connecticut Diagnostics, Ltd. — Product Code GGK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1982
Date Received
August 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Red-Cell Lysing Products
Device Class
Class I
Regulation Number
864.8540
Review Panel
HE
Submission Type

Other clearances by Connecticut Diagnostics, Ltd.

  • K905617 — VISI-STAPH (March 29, 1991)
  • K822501 — CDL ISOTONIC DILUENT (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)
  • K792340 — CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE (December 6, 1979)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)
  • K792337 — DONNECT. DIAG. CALCIUM DIAG. REAGENT (December 6, 1979)

Other clearances for product code GGK

  • K883836 — COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II (November 30, 1988)
  • K883991 — KVM HEMOGLOBIN LYSING REAGENT (October 12, 1988)
  • K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (October 20, 1987)
  • K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (September 9, 1987)
  • K863114 — PIASTRINIT (November 6, 1986)
  • K863503 — HEMOLYSE (October 3, 1986)
  • K850944 — NSI LYSING-D REAGENT -4000 ML (March 29, 1985)
  • K850097 — LASER-LYSE (March 29, 1985)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)