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510(k) K782098

REAGENT, LYSING AND HEMOGLOBIN by Dade, Baxter Travenol Diagnostics, Inc. — Product Code GGK

K782098 is an FDA 510(k) premarket notification submitted by Dade, Baxter Travenol Diagnostics, Inc. for the device "REAGENT, LYSING AND HEMOGLOBIN". The FDA issued a decision of Substantially Equivalent on January 17, 1979. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Dade, Baxter Travenol Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1979
Date Received
December 18, 1978
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 Dade, Baxter Travenol Diagnostics, Inc.

  • K800296 — WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 (March 5, 1980)
  • K792606 — WHOLE BLOOD PLATELET CONTROL NORMAL, (February 13, 1980)
  • K792723 — BLOOD FLUID FILTERS (January 21, 1980)
  • K792607 — T3 UPTAKE (T3U) REAGENTS (January 16, 1980)
  • K792443 — TSH RADIOIMMUNOASSAY (December 27, 1979)
  • K792442 — FERRITIN RADIOIMMUNOASSAY (December 18, 1979)
  • K791922 — HARLECO BRAND CLINICARD LIPASE TEST SET (November 27, 1979)
  • K792183 — DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO (November 13, 1979)
  • K790767 — IMMU-TEK AUTOMATIC CENTRIFUGE (May 23, 1979)
  • K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS) (May 23, 1979)

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