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510(k) K833933

ACE COLOR TEST by Hana Biologics, Inc. — Product Code KQN

K833933 is an FDA 510(k) premarket notification submitted by Hana Biologics, Inc. for the device "ACE COLOR TEST". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code KQN (Radioassay, Angiotensin Converting Enzyme), a Class II device regulated under 21 CFR 862.1090. Hana Biologics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
November 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Angiotensin Converting Enzyme
Device Class
Class II
Regulation Number
862.1090
Review Panel
CH
Submission Type

Other clearances by Hana Biologics, Inc.

  • K883682 — CHANG MEDIUM (ADDITIONAL INDICATIONS) (September 16, 1988)
  • K855205 — MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM (February 5, 1986)
  • K834616 — AMNIO STAT-FLM AGGLUTINATION TEST (May 25, 1984)
  • K822736 — MYCOTRIUM-GU (December 3, 1982)
  • K822737 — MYCOTRIUM-RS (December 3, 1982)
  • K822150 — AMNISTAT-FLM (October 21, 1982)
  • K812820 — CHANG MEDIUM (November 10, 1981)

Other clearances for product code KQN

  • K041657 — THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT (August 30, 2004)
  • K942497 — ANGIOTENSIN CONVERTING ENZYME REA (November 15, 1994)
  • K913091 — BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY (August 26, 1991)
  • K854876 — ALDOSTERONE DIRECT RIA KIT (March 17, 1986)
  • K854245 — SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV (January 22, 1986)
  • K821011 — ACE ACTIVITY MICROVIAL TEST SET (May 3, 1982)
  • K791712 — ANGIOTENSIN CONVERTING ENZYME ASSAY SYS (September 19, 1979)

FDA data resources