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510(k) K822737

MYCOTRIUM-RS by Hana Biologics, Inc. — Product Code JSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
September 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
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)
  • K833933 — ACE COLOR TEST (March 23, 1984)
  • K822736 — MYCOTRIUM-GU (December 3, 1982)
  • K822150 — AMNISTAT-FLM (October 21, 1982)
  • K812820 — CHANG MEDIUM (November 10, 1981)

Other clearances for product code JSI

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  • K974428 — DIPSTREAK (July 30, 1998)
  • K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM (June 9, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K882182 — SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (June 6, 1988)
  • K881572 — XL AGAR BASE (April 18, 1988)
  • K881577 — MODIFIED SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)
  • K881576 — SELENITE BROTH (April 18, 1988)
  • K881555 — TINSDALE AGAR BASE (April 18, 1988)
  • K881556 — TRICHOMONAS BROTH (April 18, 1988)