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510(k) K842874

RADIOMETRIC BLOOD CULTURE VIALS, AEROBE by American Micro Scan — Product Code JTA

K842874 is an FDA 510(k) premarket notification submitted by American Micro Scan for the device "RADIOMETRIC BLOOD CULTURE VIALS, AEROBE". The FDA issued a decision of Substantially Equivalent on September 12, 1984. The device falls under product code JTA (Monitor, Microbial Growth), a Class I device regulated under 21 CFR 866.2560. American Micro Scan has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1984
Date Received
July 23, 1984
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

Other clearances by American Micro Scan

  • K864662 — CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (March 25, 1987)
  • K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (March 25, 1987)
  • K863776 — MICRODILUTION MIC PANELS (February 2, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K864389 — CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST (December 4, 1986)
  • K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (September 30, 1986)
  • K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (September 11, 1986)
  • K862332 — ANAEROBE RAPID CHROMOGENIC ID PANEL (August 27, 1986)
  • K862140 — MICRODILUTION PANELS (July 16, 1986)
  • K861584 — GRAM NEGATIVE COMBO PANEL TYPE 3 (June 17, 1986)

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)
  • 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)
  • K790297 — DETECTION SYSTEM, MS-2 ELECTROCHEMICAL (April 26, 1979)

FDA data resources