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510(k) K872078

QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL by Solomon Park Research Laboratories — Product Code DER

K872078 is an FDA 510(k) premarket notification submitted by Solomon Park Research Laboratories for the device "QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL". The FDA issued a decision of Substantially Equivalent on June 18, 1987. The device falls under product code DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1987
Date Received
May 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5580
Review Panel
IM
Submission Type

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  • K990594 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (April 14, 1999)
  • K983289 — APOLIPOPROTEIN A1 (January 29, 1999)
  • K964296 — N-ASSAY TIA APO B TEST KIT (August 1, 1997)
  • K964292 — N-ASSAY TIA APO A1 TEST KIT (August 1, 1997)
  • K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR (August 1, 1997)
  • K910553 — ROCHE APOLIPOPROTEIN STANDARD (May 8, 1991)

FDA data resources