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510(k) K822324

RED CELL LYSING REAGENT 78N 1915-1 by Interscience, Inc. — Product Code GGK

K822324 is an FDA 510(k) premarket notification submitted by Interscience, Inc. for the device "RED CELL LYSING REAGENT 78N 1915-1". The FDA issued a decision of Substantially Equivalent on November 8, 1982. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Interscience, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1982
Date Received
August 3, 1982
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, Inc.

  • K822327 — CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT (November 16, 1982)
  • K822325 — BLOOD CELL DILUENT 78N 1913 (October 18, 1982)
  • K822326 — BLENDED DETERGENT-78N 1912-1 (October 18, 1982)

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