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510(k) K883001

QM300 CALIBRATOR D PACK by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code CZJ

K883001 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "QM300 CALIBRATOR D PACK". The FDA issued a decision of Substantially Equivalent on September 22, 1988. The device falls under product code CZJ (Igd, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. 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
Igd, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
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 CZJ

  • K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS (December 28, 2009)
  • K051299 — IGD DIAGNOSTIC TEST KITS (November 23, 2005)
  • K002561 — SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT (October 26, 2000)
  • K913671 — HUMAN IGD IMMUNOLOGICAL NL TEST KIT (December 2, 1991)
  • K872834 — TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 (August 12, 1987)
  • K831956 — DETERM. SIZE 72 RADIAL-HUMAN IGD (July 18, 1983)
  • K772327 — LAS-R HUMAN IGD TEST (February 28, 1978)

FDA data resources