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510(k) K880129

BRILLIANT GREEN BILE BROTH by Hardy Media — Product Code JSF

K880129 is an FDA 510(k) premarket notification submitted by Hardy Media for the device "BRILLIANT GREEN BILE BROTH". The FDA issued a decision of Substantially Equivalent on Mar 30, 1988. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. 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, Single Biochemical Test
Device Class
Class I
Regulation Number
866.2320
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)
  • K880123 — LOWENSTEIN-JENSEN SLANT (Mar 31, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (Mar 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (Mar 31, 1988)
  • K880125 — LOWENSTEIN-JENSEN, SELECTIVE (Mar 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (Mar 31, 1988)
  • K880124 — LOWENSTEIN-JENSEN, W/NACL (Mar 31, 1988)

Other clearances for product code JSF

  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (Apr 1, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (Mar 31, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (Mar 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (Mar 31, 1988)
  • K880118 — MOELLOERS DECARBOXYLASE, ARGININE (Mar 30, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (Mar 30, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (Mar 30, 1988)
  • K880139 — ONPG TEST REAGENT (Mar 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (Mar 30, 1988)
  • K880110 — CYSTINE TRYPTIC MEDIUM W/DEXTROSE (Mar 30, 1988)

FDA data resources

Source: FDA 510(k) database entry for K880129. Report a data issue: hello@regdatalab.com.