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510(k) K881579

AMIES TRANSPORT MEDIUM W/O CHARCOAL by Acumedia Manufacturers, Inc. — Product Code JSN

K881579 is an FDA 510(k) premarket notification submitted by Acumedia Manufacturers, Inc. for the device "AMIES TRANSPORT MEDIUM W/O CHARCOAL". The FDA issued a decision of Substantially Equivalent on April 18, 1988. The device falls under product code JSN (Culture Media, Propagating Transport), a Class I device regulated under 21 CFR 866.2390. 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, Propagating Transport
Device Class
Class I
Regulation Number
866.2390
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 JSN

  • K000718 — CHROMOSTREAK (August 24, 2000)
  • K962745 — ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) (October 2, 1996)
  • K961756 — CYTOQUANT VIRAL TRANSPORT MEDIUM (May 17, 1996)
  • K961755 — CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM (May 17, 1996)
  • K896296 — INPOUCH-TV POUCH (January 29, 1990)
  • K860967 — VIRTRAN VIRAL TRANSPORTER (MODIFIED) (April 4, 1986)
  • K841208 — PROPAGATING TRANSPORT (April 5, 1984)
  • K833968 — 10B (December 30, 1983)
  • K834065 — A3B (December 27, 1983)
  • K831186 — RAPID NFT (May 9, 1983)

FDA data resources