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510(k) K881573

PHYTONE YEAST EXTRACT AGAR by Acumedia Manufacturers, Inc. — Product Code JSJ

K881573 is an FDA 510(k) premarket notification submitted by Acumedia Manufacturers, Inc. for the device "PHYTONE YEAST EXTRACT AGAR". The FDA issued a decision of Substantially Equivalent on April 18, 1988. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Acumedia Manufacturers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1988
Date Received
April 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
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 JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881570 — SABOURAUD MALTOSE AGAR (April 18, 1988)

FDA data resources