Home / 510(k) Clearances / K802610

510(k) K802610

ALERT A,HDL-APOLIPOROTEIN A, TEST KIT by Hyland Therapeutic Div., Travenol Laboratories — Product Code DER

K802610 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "ALERT A,HDL-APOLIPOROTEIN A, TEST KIT". The FDA issued a decision of Substantially Equivalent on January 5, 1981. The device falls under product code DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5580. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1981
Date Received
October 21, 1980
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 Hyland Therapeutic Div., Travenol Laboratories

  • K820835 — ALUMINA SILICA-ACTIVATED PARTIAL THROM (April 26, 1982)
  • K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (March 11, 1982)
  • K812220 — NEPHELOMETRIC SOLID TURBIDITY STANDARD (August 18, 1981)
  • K810078 — Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S (February 2, 1981)
  • K810077 — OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. (January 28, 1981)
  • K791113 — LOW IONIC STRENGTH SOLUTION (LISS) (June 28, 1979)
  • K790249 — TEST CELLS (May 16, 1979)
  • K781225 — GLOBULIN TEST, HUMAN THYROXINE BINDING (August 31, 1978)
  • K780962 — AUTOMATED ENZYME (July 27, 1978)
  • K780785 — DILUTOR TRANSPORTER (June 14, 1978)

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)
  • K964292 — N-ASSAY TIA APO A1 TEST KIT (August 1, 1997)
  • K964296 — N-ASSAY TIA APO B 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