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510(k) K931234

HEMOCARD CONTROL HB-AA, AE, FAA, FAE by Isolab, Inc. — Product Code JCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1993
Date Received
March 10, 1993
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.

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  • 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)
  • K923153 — HEMOCARD, HEMOGLOBIN C ASSAY (January 27, 1994)

Other clearances for product code JCM

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  • K011389 — HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) (June 21, 2001)
  • K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (February 10, 1999)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • K933086 — AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 (October 31, 1994)
  • 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)