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510(k) K790297

DETECTION SYSTEM, MS-2 ELECTROCHEMICAL by Abbott Laboratories — Product Code JTA

K790297 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "DETECTION SYSTEM, MS-2 ELECTROCHEMICAL". The FDA issued a decision of Substantially Equivalent on April 26, 1979. The device falls under product code JTA (Monitor, Microbial Growth), a Class I device regulated under 21 CFR 866.2560. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1979
Date Received
February 9, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Microbial Growth
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type

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Other clearances for product code JTA

  • K954923 — BACTEC FUNGAL MEDIUM (November 21, 1996)
  • K910835 — BACTEC NR-860 (March 11, 1991)
  • K865021 — BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM (February 6, 1987)
  • K853011 — BACTEC NR-730 BACTERIAL DETECTION SYSTEM (July 30, 1985)
  • K842874 — RADIOMETRIC BLOOD CULTURE VIALS, AEROBE (September 12, 1984)
  • K842279 — BECTEC NR-660 BACTERIAL DETECT SYS (July 20, 1984)
  • K833917 — BAC-T-SCREEN (January 13, 1984)
  • K834264 — REVERSE-FLOW SYSTEM (January 13, 1984)
  • K810042 — BACTEC BACTERIAL DETECTION SYSTEM: #5 (January 28, 1981)
  • K792575 — BACTEC BACTERIAL DETECTION SYSTEM (December 27, 1979)

FDA data resources