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510(k) K834264

REVERSE-FLOW SYSTEM by Applied Polytechnology, Inc. — Product Code JTA

K834264 is an FDA 510(k) premarket notification submitted by Applied Polytechnology, Inc. for the device "REVERSE-FLOW SYSTEM". The FDA issued a decision of Substantially Equivalent on January 13, 1984. The device falls under product code JTA (Monitor, Microbial Growth), a Class I device regulated under 21 CFR 866.2560. Applied Polytechnology, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1984
Date Received
December 8, 1983
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 Applied Polytechnology, Inc.

  • K860483 — FILTRA-CHECK-UTI (April 4, 1986)
  • K843834 — BACTERIURIA DETECT. DEVICE APTEK II (November 29, 1984)
  • K843833 — BACTERIURIA DETECT DEVICE, MULTI SAMPLER (November 29, 1984)
  • K843359 — URINE TRANSPORT KIT (September 27, 1984)
  • K843316 — INDOLE SPOT TEST KIT 270-25 (September 11, 1984)
  • K840257 — RAPID IMMUNO-ASSAY SYS (April 19, 1984)

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)
  • 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