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510(k) K823311

COLUMBIA V AGAR W/5% HUMAN BLOOD by Troy Biologicals, Inc. — Product Code JSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1982
Date Received
November 5, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

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  • K832861 — SABOURAUD DEXTROSE AGAR (September 26, 1983)
  • K823307 — CAMPYLOBACTER SELECTIVE AGAR (December 15, 1982)
  • K823310 — STREPTOCOCCUS SELECTIVE AGAR (December 15, 1982)
  • K823306 — HEMOPHILUS QUAD 10 PLATE (December 15, 1982)
  • K823308 — MYCAREL AGAR MYCOBROTIC AGAR (December 3, 1982)
  • K823309 — MARTIN & LEMIS AGAR W/VCAT INHIBITOR (December 3, 1982)

Other clearances for product code JSH

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  • K881559 — UREA AGAR BASE (April 18, 1988)
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  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)