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510(k) K880136

CETRIMIDE SELECTIVE AGAR by Hardy Media — Product Code JSJ

K880136 is an FDA 510(k) premarket notification submitted by Hardy Media for the device "CETRIMIDE SELECTIVE AGAR". The FDA issued a decision of Substantially Equivalent on Mar 30, 1988. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Hardy Media has 113 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 30, 1988
Date Received
Jan 6, 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
510(k) Exempt

Other clearances by Hardy Media

  • K880126 — LAURYL TRYPTOSE BROTH (Mar 31, 1988)
  • K880116 — MRVP BROTH (Mar 31, 1988)
  • K880133 — MIL MEDIUM (Mar 31, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (Mar 31, 1988)
  • K880125 — LOWENSTEIN-JENSEN, SELECTIVE (Mar 31, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (Mar 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (Mar 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (Mar 31, 1988)
  • K880123 — LOWENSTEIN-JENSEN SLANT (Mar 31, 1988)
  • K880124 — LOWENSTEIN-JENSEN, W/NACL (Mar 31, 1988)

Other clearances for product code JSJ

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

FDA data resources