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510(k) K830186

LYSIS + by Hematology Marketing Assoc. — Product Code GGK

K830186 is an FDA 510(k) premarket notification submitted by Hematology Marketing Assoc. for the device "LYSIS +". The FDA issued a decision of Substantially Equivalent on February 28, 1983. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Hematology Marketing Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1983
Date Received
January 19, 1983
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 Hematology Marketing Assoc.

  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851375 — TRI-COUNT (July 12, 1985)
  • K850097 — LASER-LYSE (March 29, 1985)
  • K850095 — LASER-DIL (March 29, 1985)
  • K850094 — LASER-GLOBIN POWDER (March 29, 1985)
  • K850096 — LASER-GLOBIN (March 29, 1985)
  • K844708 — TRI-COUNT CALIBRATOR (March 5, 1985)
  • K843485 — TRI-COUNT LASER (December 12, 1984)
  • K834371 — TRI-COUNT 10 (March 9, 1984)
  • K833130 — TRI-COUNT 7 (October 20, 1983)

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