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510(k) K883002

QM300 PREALBUMIN ANTIBODY PACK by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code JZJ

K883002 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "QM300 PREALBUMIN ANTIBODY PACK". The FDA issued a decision of Substantially Equivalent on September 22, 1988. The device falls under product code JZJ (Prealbumin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5060. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1988
Date Received
July 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prealbumin, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5060
Review Panel
IM
Submission Type

Other clearances by Kallestad Diag, A Div. of Erbamont, Inc.

  • K910885 — QM300 CALIBRATOR G PACK (June 17, 1991)
  • K910886 — QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK (June 17, 1991)
  • K910887 — QM300 CONTROL G PACK (June 17, 1991)
  • K904725 — CHLAMYDIA SYSTEM SOFTWARE (CSS) (January 14, 1991)
  • K902253 — PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT (July 26, 1990)
  • K902462 — MODIFIED QM300 RHEUMATOID FACTOR TEST (June 21, 1990)
  • K900010 — NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR (April 3, 1990)
  • K897072 — NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR (March 29, 1990)
  • K900009 — NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET (March 29, 1990)
  • K894947 — PLATELIA TOXO IGG KIT (March 23, 1990)

Other clearances for product code JZJ

  • K000661 — RANDOX PREALBUMIN (April 13, 2000)
  • K972638 — TINA-QUANT PREALBUMIN (January 9, 1998)
  • K951966 — HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (June 1, 1995)
  • K913672 — PREALBUMIN IMMUNOLOGICAL NL TEST KIT (December 20, 1991)
  • K884298 — SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (November 2, 1988)
  • K884297 — SPQ(TM) TEST SYSTEM FOR PREALBUMIN (November 2, 1988)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
  • K851912 — LASER PREALBUMIN TEST (June 21, 1985)
  • K821135 — PREALBUMIN ENZYME IMMUNOASSAY (May 5, 1983)
  • K772329 — LAS-R HUMAN PREALBUMIN TEST (February 3, 1978)

FDA data resources