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510(k) K842069

IDL-LYSING REAGENT by Interscience Diagnostics, Inc. — Product Code GGK

K842069 is an FDA 510(k) premarket notification submitted by Interscience Diagnostics, Inc. for the device "IDL-LYSING REAGENT". The FDA issued a decision of Substantially Equivalent on July 2, 1984. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Interscience Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1984
Date Received
May 23, 1984
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 Interscience Diagnostics, Inc.

  • K854166 — HEMATOLOGY CALIBRATOR CONTROL (March 12, 1986)
  • K842070 — IDD DETERGENT (July 2, 1984)
  • K842068 — IDI ISOTONIC DILUENT (July 2, 1984)

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