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510(k) K832616

MACCONKEY AGAR MEDIA by Carroll Biological Corp. — Product Code JSH

K832616 is an FDA 510(k) premarket notification submitted by Carroll Biological Corp. for the device "MACCONKEY AGAR MEDIA". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. 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, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
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)
  • K832619 — THIOGLYCOLLATE MEDIUM (September 12, 1983)
  • K832613 — MANNITOL SALT AGAR (September 12, 1983)
  • K832617 — XYLOSE LYSINE DEOXYCHOLATE (September 12, 1983)
  • K832615 — SF BROTH (September 12, 1983)

Other clearances for product code JSH

  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881540 — FLO 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)

FDA data resources