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510(k) K853048

APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 by Photec Diagnostics, Inc. — Product Code DER

K853048 is an FDA 510(k) premarket notification submitted by Photec Diagnostics, Inc. for the device "APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1". The FDA issued a decision of Substantially Equivalent on August 28, 1985. The device falls under product code DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5580. Photec Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1985
Date Received
July 19, 1985
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

Other clearances by Photec Diagnostics, Inc.

  • K897169 — QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT (February 23, 1990)
  • K896329 — D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. (December 12, 1989)
  • K894057 — QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT (August 31, 1989)
  • K892224 — D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN (June 16, 1989)
  • K890267 — QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA (April 26, 1989)
  • K890027 — QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD (April 26, 1989)
  • K882307 — D-CHEM (August 2, 1988)
  • K880291 — THEOPHYLLINE TEST KIT REF. #A874799 (March 24, 1988)
  • K854875 — APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 (January 24, 1986)
  • K853174 — APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN (August 22, 1985)

Other clearances for product code DER

  • K013249 — TINA-QUANT APOLIPOPROTEIN VER.2 (November 16, 2001)
  • K000921 — BAYER ADVIA IMS SYSTEM; 200 + 3 (May 18, 2000)
  • K993354 — K-ASSAY APO B (October 28, 1999)
  • K993345 — K-ASSAY APO AI (October 25, 1999)
  • K990594 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (April 14, 1999)
  • K983289 — APOLIPOPROTEIN A1 (January 29, 1999)
  • K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR (August 1, 1997)
  • K964296 — N-ASSAY TIA APO B TEST KIT (August 1, 1997)
  • K964292 — N-ASSAY TIA APO A1 TEST KIT (August 1, 1997)
  • K910553 — ROCHE APOLIPOPROTEIN STANDARD (May 8, 1991)

FDA data resources