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510(k) K942222

QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS by Isolab, Inc. — Product Code JCM

K942222 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS". The FDA issued a decision of Substantially Equivalent on January 20, 1995. The device falls under product code JCM (Control, Hemoglobin, Abnormal), 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 20, 1995
Date Received
May 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hemoglobin, Abnormal
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)
  • K944185 — ISOSCAN (November 17, 1994)
  • K934013 — RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (April 26, 1994)
  • K923153 — HEMOCARD, HEMOGLOBIN C ASSAY (January 27, 1994)
  • K931234 — HEMOCARD CONTROL HB-AA, AE, FAA, FAE (May 11, 1993)

Other clearances for product code JCM

  • K053031 — EXTENDSURE HBFASC CONTROL (December 7, 2005)
  • K011389 — HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) (June 21, 2001)
  • K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (February 10, 1999)
  • K933086 — AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 (October 31, 1994)
  • K931234 — HEMOCARD CONTROL HB-AA, AE, FAA, FAE (May 11, 1993)
  • K924173 — HEMOCARD(TM) CONTROL (December 1, 1992)
  • K913427 — SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (November 19, 1991)
  • K911347 — LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL (June 10, 1991)
  • K910431 — HEMOCARD CONTROL (March 11, 1991)
  • K820787 — HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL (April 8, 1982)

FDA data resources