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510(k) K880139

ONPG TEST REAGENT by Hardy Media — Product Code JSF

K880139 is an FDA 510(k) premarket notification submitted by Hardy Media for the device "ONPG TEST REAGENT". The FDA issued a decision of Substantially Equivalent on March 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1988
Date Received
January 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

Other clearances by Hardy Media

  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880124 — LOWENSTEIN-JENSEN, W/NACL (March 31, 1988)
  • K880123 — LOWENSTEIN-JENSEN SLANT (March 31, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880116 — MRVP BROTH (March 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880125 — LOWENSTEIN-JENSEN, SELECTIVE (March 31, 1988)
  • K880133 — MIL MEDIUM (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)
  • K880129 — BRILLIANT GREEN BILE BROTH (March 30, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (March 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (March 30, 1988)
  • K880135 — NITRATE BROTH (March 30, 1988)
  • K880110 — CYSTINE TRYPTIC MEDIUM W/DEXTROSE (March 30, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (March 30, 1988)

FDA data resources