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510(k) K823001

PEPTONE IRON AGAR by Granite Diagnostics, Inc. — Product Code JSF

K823001 is an FDA 510(k) premarket notification submitted by Granite Diagnostics, Inc. for the device "PEPTONE IRON AGAR". The FDA issued a decision of Substantially Equivalent on November 16, 1982. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Granite Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1982
Date Received
October 12, 1982
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 Granite Diagnostics, Inc.

  • K850970 — BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA (March 29, 1985)
  • K850969 — INHIBITORY MOLD AGAR PLATE (March 29, 1985)
  • K833254 — STREPTOCOCCUS ID TRIPLATE SYSTEM (October 28, 1983)
  • K832365 — TCBS AGAR (September 1, 1983)
  • K831349 — STREPTOCOCUS ID PLATE (May 16, 1983)
  • K830252 — DIPCHEX DIP-SLIDE CULTURE SYS (March 7, 1983)
  • K830251 — CAMPY BLOOD AGAR PLATE (February 28, 1983)
  • K823248 — SCHAEDLER AGARS (December 3, 1982)
  • K823139 — SMITH'S MEDIUM (December 3, 1982)
  • K823122 — LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM (December 3, 1982)

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)
  • K880110 — CYSTINE TRYPTIC MEDIUM W/DEXTROSE (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