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510(k) K913427

SICKLE HEMOGLOBIN (HBA/S) CONTROL SET by Creative Laboratory Products, Inc. — Product Code JCM

K913427 is an FDA 510(k) premarket notification submitted by Creative Laboratory Products, Inc. for the device "SICKLE HEMOGLOBIN (HBA/S) CONTROL SET". The FDA issued a decision of Substantially Equivalent on November 19, 1991. The device falls under product code JCM (Control, Hemoglobin, Abnormal), a Class II device regulated under 21 CFR 864.7415. Creative Laboratory Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1991
Date Received
August 1, 1991
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 Creative Laboratory Products, Inc.

  • K950589 — CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL (March 20, 1995)
  • K942284 — CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET (August 26, 1994)
  • K922995 — LIPID CONTROLS (August 12, 1992)
  • K913371 — TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL (November 8, 1991)
  • K913585 — LIPASE LINEARITY CONTROL (October 21, 1991)
  • K913224 — LIPID LINEARITY CONTROLS (September 25, 1991)
  • K913496 — CHOLINESTERASE LINEARITY CONTROL (September 11, 1991)
  • K912823 — HIGH DENSITY LIPOPROTEIN CHOLESTEROL (August 16, 1991)
  • K912725 — TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL (July 30, 1991)
  • K904989 — CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II (January 23, 1991)

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)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • 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)
  • 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