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510(k) K840289

LYSE-TEC by Medilab Corp. — Product Code GGK

K840289 is an FDA 510(k) premarket notification submitted by Medilab Corp. for the device "LYSE-TEC". The FDA issued a decision of Substantially Equivalent on March 5, 1984. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Medilab Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1984
Date Received
January 24, 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 Medilab Corp.

  • K841862 — IMMU-TEC (June 13, 1984)
  • K841863 — MONO-TEC (June 13, 1984)
  • K840291 — MCS ALBUMIN REAGENT (March 30, 1984)
  • K840290 — MCS TOTAL PROTEIN REAGENT (March 30, 1984)
  • K832918 — PREGNA-TEC (November 3, 1983)
  • K832527 — PREGNA-TEC (September 12, 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)
  • 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