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510(k) K830437

CHS by Dms Laboratories — Product Code JSC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1983
Date Received
February 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, General Nutrient Broth
Device Class
Class I
Regulation Number
866.2350
Review Panel
MI
Submission Type

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  • K813612 — RAPID ZYME (February 22, 1982)
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  • K820211 — NINHYDRIN (February 12, 1982)
  • K820210 — IND (February 12, 1982)
  • K820212 — OXI (February 12, 1982)
  • K820209 — ZYME B (February 12, 1982)

Other clearances for product code JSC

  • K850143 — SPORDEX CULTURE MEDIA (March 5, 1985)
  • K842849 — TRYPTICASE SOY BROTH (August 3, 1984)
  • K842852 — BRAIN HEART INFUSION BROTH (August 3, 1984)
  • K841221 — BRAIN HEART INFUSION BROTH (April 4, 1984)
  • K841219 — SHOPPED MEAT CARBOHYDRATE (April 4, 1984)
  • K833300 — SABOURAUD BHI AGAR (November 7, 1983)
  • K832570 — EXTRACT BROTH (September 12, 1983)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832619 — THIOGLYCOLLATE MEDIUM (September 12, 1983)
  • K832569 — INFUSION BROTH (September 12, 1983)