Home / 510(k) Clearances / K833300

510(k) K833300

SABOURAUD BHI AGAR by Acumedia Manufacturers, Inc. — Product Code JSC

K833300 is an FDA 510(k) premarket notification submitted by Acumedia Manufacturers, Inc. for the device "SABOURAUD BHI AGAR". The FDA issued a decision of Substantially Equivalent on November 7, 1983. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. Acumedia Manufacturers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1983
Date Received
September 22, 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 Acumedia Manufacturers, Inc.

  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)

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)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832619 — THIOGLYCOLLATE MEDIUM (September 12, 1983)
  • K832570 — EXTRACT BROTH (September 12, 1983)
  • K832569 — INFUSION BROTH (September 12, 1983)
  • K830437 — CHS (March 17, 1983)

FDA data resources