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510(k) K843122

RESOLVE-CSF by Isolab, Inc. — Product Code DFI

K843122 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "RESOLVE-CSF". The FDA issued a decision of Substantially Equivalent on November 30, 1984. The device falls under product code DFI (Total Spinal-Fluid, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5860. Isolab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1984
Date Received
August 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Total Spinal-Fluid, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5860
Review Panel
IM
Submission Type

Other clearances by Isolab, Inc.

  • K951014 — ISOLAB'S T4 TEST KIT (October 18, 1996)
  • K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (February 1, 1996)
  • K943547 — PHENYLALANINE TEST KIT (January 26, 1996)
  • K950803 — ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE (September 21, 1995)
  • K950415 — FLUOROSCAN NEONATAL (September 5, 1995)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • K942276 — QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (January 20, 1995)
  • K944185 — ISOSCAN (November 17, 1994)
  • K934013 — RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (April 26, 1994)
  • K923153 — HEMOCARD, HEMOGLOBIN C ASSAY (January 27, 1994)

Other clearances for product code DFI

  • K854190 — CANTROL SPINAL FLUID CONTROL (November 25, 1985)
  • K840974 — SOMAS HUMAN SPINAL FLUID CONTROL (April 5, 1984)
  • K832821 — FIAX IGG TEST (October 14, 1983)

FDA data resources