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510(k) K761182

ISOTONIC DILUENT AF by Central Labs. Assoc. MD Pathologists — Product Code GGK

K761182 is an FDA 510(k) premarket notification submitted by Central Labs. Assoc. MD Pathologists for the device "ISOTONIC DILUENT AF". The FDA issued a decision of Substantially Equivalent on December 9, 1976. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Central Labs. Assoc. MD Pathologists has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1976
Date Received
December 2, 1976
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 Central Labs. Assoc. MD Pathologists

  • K771201 — FORMALIN BUFFER CONCENTRATE (August 22, 1977)
  • K761183 — LYSING AGENT AF (January 17, 1977)

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)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)

FDA data resources