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510(k) K923153

HEMOCARD, HEMOGLOBIN C ASSAY by Isolab, Inc. — Product Code MLL

K923153 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "HEMOCARD, HEMOGLOBIN C ASSAY". The FDA issued a decision of Substantially Equivalent on January 27, 1994. The device falls under product code MLL (Hemoglobin C (Abnormal Hemoglobin Variant)), a Class II device regulated under 21 CFR 864.7415. Isolab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1994
Date Received
June 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin C (Abnormal Hemoglobin Variant)
Device Class
Class II
Regulation Number
864.7415
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)
  • K942276 — QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (January 20, 1995)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • K944185 — ISOSCAN (November 17, 1994)
  • K934013 — RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (April 26, 1994)
  • K931234 — HEMOCARD CONTROL HB-AA, AE, FAA, FAE (May 11, 1993)

FDA data resources