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510(k) K770746

PANEL, IDENTIFICATION, STREP, MICRO-ID by Micro-Media Systems, Inc. — Product Code JSE

K770746 is an FDA 510(k) premarket notification submitted by Micro-Media Systems, Inc. for the device "PANEL, IDENTIFICATION, STREP, MICRO-ID". The FDA issued a decision of Substantially Equivalent on June 23, 1977. The device falls under product code JSE (Culture Media, Multiple Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Micro-Media Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1977
Date Received
April 22, 1977
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 Micro-Media Systems, Inc.

  • K953422 — FOX FASTIDIOUS TEST PANELS (October 7, 1995)
  • K945997 — MODIFIED FOX EXTRA GRAM POSITIVE (February 16, 1995)
  • K823738 — GRAM NEGATIVE BACTERIAL IDENTIF- PANELS (January 7, 1983)
  • K801547 — TEST PANEL FOR PRESUMP. ID/BACT. ORG (September 9, 1980)
  • K791991 — STREP-SPEC (November 13, 1979)
  • K770745 — PANEL, GNF, MICRO-ID (June 23, 1977)

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)
  • K860412 — BIOTIS SIM MEDIUM (February 24, 1986)

FDA data resources