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510(k) K822998

CHRISTENSENS CITRATE SULFIDE AGAR by Granite Diagnostics, Inc. — Product Code JSE

K822998 is an FDA 510(k) premarket notification submitted by Granite Diagnostics, Inc. for the device "CHRISTENSENS CITRATE SULFIDE AGAR". The FDA issued a decision of Substantially Equivalent on November 16, 1982. The device falls under product code JSE (Culture Media, Multiple 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, Multiple Biochemical Test
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Granite Diagnostics, Inc.

  • K850969 — INHIBITORY MOLD AGAR PLATE (March 29, 1985)
  • K850970 — BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA (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 JSE

  • K962265 — MLX MICROTITER PLATE LUMINOMETER (July 25, 1996)
  • K883995 — X-ACT UREA/TDA (October 12, 1988)
  • K883996 — X-ACT LDC/IND (October 12, 1988)
  • K880133 — MIL MEDIUM (March 31, 1988)
  • K880116 — MRVP BROTH (March 31, 1988)
  • K874537 — KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (November 20, 1987)
  • K871096 — CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES (April 3, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K860414 — BIOTIS ORNITHINE INDOLE MOTILITY MEDIA (February 24, 1986)

FDA data resources