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510(k) K820630

QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL by Isolab, Inc. — Product Code JPC

K820630 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL". The FDA issued a decision of Substantially Equivalent on June 25, 1982. The device falls under product code JPC (Hemoglobin F Quantitation), a Class II device regulated under 21 CFR 864.7455. Isolab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1982
Date Received
March 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin F Quantitation
Device Class
Class II
Regulation Number
864.7455
Review Panel
HE
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)

FDA data resources