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510(k) K832182

LYSING REAGENT by Omega Medical Diagnostics — Product Code GGK

K832182 is an FDA 510(k) premarket notification submitted by Omega Medical Diagnostics for the device "LYSING REAGENT". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Omega Medical Diagnostics has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
July 7, 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 Omega Medical Diagnostics

  • K831620 — SODIUM HYPOCHLORITE 3% (July 28, 1983)
  • K831619 — SODIUM HYPOCHLORITE 7% (July 28, 1983)
  • K831617 — DILUENT (June 16, 1983)
  • K831618 — HEMOGLOBIN REAGENT (June 16, 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)
  • K850097 — LASER-LYSE (March 29, 1985)
  • K850944 — NSI LYSING-D REAGENT -4000 ML (March 29, 1985)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)

FDA data resources