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510(k) K841840

SELECTIVE CULTURE MED. PHENYLETHYL ALCO by Microline Scientific — Product Code JSJ

K841840 is an FDA 510(k) premarket notification submitted by Microline Scientific for the device "SELECTIVE CULTURE MED. PHENYLETHYL ALCO". The FDA issued a decision of Substantially Equivalent on May 25, 1984. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Microline Scientific has 13 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1984
Date Received
Apr 17, 1984
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
510(k) Exempt

Other clearances by Microline Scientific

  • K841842 — DIFFERENTIAL CULTURE MED. MACCONKEY AGAR (May 31, 1984)
  • K841845 — SELECTIVE CULTURE MED. COLUMBIA CNA (May 31, 1984)
  • K841586 — CHOCOLATE AGAR (May 31, 1984)
  • K841843 — DIFFERENTIAL CULTURE MED. LEVINE EMB (May 31, 1984)
  • K841844 — DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR (May 31, 1984)
  • K841841 — DIFFERENTIAL CULTURE MED. MANNITOL SALT (May 25, 1984)
  • K841839 — SELECTIVE CULTURE MED. SELECTIVE STREP (May 25, 1984)
  • K841837 — ENRICHED CULTURE MED. FLUID THIOGLYC0 (May 21, 1984)
  • K841838 — ENRICHED CULTURE MED. TRYPTIC SOY AGAR (May 21, 1984)
  • K841835 — MULTIPURPOSE CULTURE MEDIUM (May 14, 1984)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (Jun 22, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (Apr 18, 1988)
  • K881544 — LITTMAN AGAR (Apr 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (Apr 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (Apr 18, 1988)
  • K881578 — STREPTOSEL (Apr 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (Apr 18, 1988)
  • K881571 — YM BROTH (Apr 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (Apr 18, 1988)
  • K881561 — TERGITOL 7 BROTH (Apr 18, 1988)

FDA data resources

Source: FDA 510(k) database entry for K841840. Report a data issue: hello@regdatalab.com.