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510(k) K820560

PHENYLETHANOL AGAR W/5% SHEEP BLOOD by American Laboratory Supply, Inc. — Product Code JSJ

K820560 is an FDA 510(k) premarket notification submitted by American Laboratory Supply, Inc. for the device "PHENYLETHANOL AGAR W/5% SHEEP BLOOD". The FDA issued a decision of Substantially Equivalent on March 19, 1982. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. American Laboratory Supply, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1982
Date Received
March 2, 1982
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 American Laboratory Supply, Inc.

  • K852578 — CLED AGAR (July 12, 1985)
  • K844932 — MALT AGAR (February 27, 1985)
  • K844931 — MYCOLOGICAL AGAR W/ANTIBIOTICS (February 27, 1985)
  • K844929 — INHIBITORY MOLD AGAR (February 27, 1985)
  • K844933 — BILE ESCULIN AGAR (February 27, 1985)
  • K844930 — BRILLANT GREEN AGAR (February 27, 1985)
  • K844934 — AZIDE AGAR W/5% SHEEP BLOOD (February 25, 1985)
  • K820562 — CAMPYLOBACTER SELECTIVE MEDIUM (March 19, 1982)
  • K820550 — POTATO DEXTROSE AGAR (March 19, 1982)
  • K820559 — ANAEROBE BLOOD AGAR (March 19, 1982)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT 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)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)

FDA data resources