Home / 510(k) Clearances / K870641

510(k) K870641

TRYPTONE BROTH, 2% by Hardy Media — Product Code JSF

K870641 is an FDA 510(k) premarket notification submitted by Hardy Media for the device "TRYPTONE BROTH, 2%". The FDA issued a decision of Substantially Equivalent on April 14, 1987. 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1987
Date Received
February 13, 1987
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

Other clearances by Hardy Media

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

Other clearances for product code JSF

  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (April 1, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (March 31, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880135 — NITRATE BROTH (March 30, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (March 30, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (March 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (March 30, 1988)
  • K880139 — ONPG TEST REAGENT (March 30, 1988)
  • K880129 — BRILLIANT GREEN BILE BROTH (March 30, 1988)

FDA data resources