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510(k) K881531

BLOOD AGAR BASE, IMPROVED by Acumedia Manufacturers, Inc. — Product Code JSG

K881531 is an FDA 510(k) premarket notification submitted by Acumedia Manufacturers, Inc. for the device "BLOOD AGAR BASE, IMPROVED". The FDA issued a decision of Substantially Equivalent on Apr 18, 1988. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Acumedia Manufacturers, Inc. has 176 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 18, 1988
Date Received
Apr 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type
510(k) Exempt

Other clearances by Acumedia Manufacturers, Inc.

  • K881573 — PHYTONE YEAST EXTRACT AGAR (Apr 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (Apr 18, 1988)
  • K881571 — YM BROTH (Apr 18, 1988)
  • K881558 — TRYPTOSE AGAR (Apr 18, 1988)
  • K881544 — LITTMAN AGAR (Apr 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (Apr 18, 1988)
  • K881548 — MPH AGAR (Apr 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (Apr 18, 1988)
  • K881566 — HEMOGLOBIN POWDER (Apr 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (Apr 18, 1988)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (Jul 1, 1988)
  • K881542 — HEART INFUSION AGAR (Apr 18, 1988)
  • K881550 — OF BASAL MEDIUM (Apr 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (Apr 18, 1988)
  • K881548 — MPH AGAR (Apr 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (Apr 18, 1988)
  • K881541 — GELATIN (Apr 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (Apr 18, 1988)
  • K881558 — TRYPTOSE AGAR (Apr 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (Apr 18, 1988)

FDA data resources