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510(k) K832619

THIOGLYCOLLATE MEDIUM by Carroll Biological Corp. — Product Code JSC

K832619 is an FDA 510(k) premarket notification submitted by Carroll Biological Corp. for the device "THIOGLYCOLLATE MEDIUM". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. Carroll Biological Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 8, 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

Other clearances by Carroll Biological Corp.

  • K832243 — CULTURE MEDIUM FOR ANTIMICROBIAL SUS (September 29, 1983)
  • K832611 — TRYPTIC SOY AGAR (September 12, 1983)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832618 — BLUE AGAR (September 12, 1983)
  • K832614 — SELENITE BROTH (September 12, 1983)
  • K832612 — CHOCOLATE AGAR & THAYER MARTIN AGAR (September 12, 1983)
  • K832613 — MANNITOL SALT AGAR (September 12, 1983)
  • K832616 — MACCONKEY AGAR MEDIA (September 12, 1983)
  • K832617 — XYLOSE LYSINE DEOXYCHOLATE (September 12, 1983)
  • K832615 — SF BROTH (September 12, 1983)

Other clearances for product code JSC

  • K850143 — SPORDEX CULTURE MEDIA (March 5, 1985)
  • K842852 — BRAIN HEART INFUSION BROTH (August 3, 1984)
  • K842849 — TRYPTICASE SOY 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)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832570 — EXTRACT BROTH (September 12, 1983)
  • K832569 — INFUSION BROTH (September 12, 1983)
  • K830437 — CHS (March 17, 1983)

FDA data resources