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510(k) K880123

LOWENSTEIN-JENSEN SLANT by Hardy Media — Product Code JSJ

K880123 is an FDA 510(k) premarket notification submitted by Hardy Media for the device "LOWENSTEIN-JENSEN SLANT". The FDA issued a decision of Substantially Equivalent on March 31, 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1988
Date Received
January 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

Other clearances by Hardy Media

  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880116 — MRVP BROTH (March 31, 1988)
  • K880124 — LOWENSTEIN-JENSEN, W/NACL (March 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880125 — LOWENSTEIN-JENSEN, SELECTIVE (March 31, 1988)
  • K880133 — MIL MEDIUM (March 31, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (March 31, 1988)

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