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510(k) K883991

KVM HEMOGLOBIN LYSING REAGENT by Kvm Technologies, Inc. — Product Code GGK

K883991 is an FDA 510(k) premarket notification submitted by Kvm Technologies, Inc. for the device "KVM HEMOGLOBIN LYSING REAGENT". The FDA issued a decision of Substantially Equivalent on October 12, 1988. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Kvm Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1988
Date Received
September 20, 1988
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 Kvm Technologies, Inc.

  • K925666 — THERAPACER 3000 (March 9, 1993)
  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K883989 — KVM ISOTONIC FLUSH SOLUTION (October 12, 1988)
  • K883992 — KVM PREPACK HEMATOLOGY REAGENT SET (October 12, 1988)

Other clearances for product code GGK

  • K883836 — COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II (November 30, 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)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)

FDA data resources