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510(k) K833917

BAC-T-SCREEN by Marion Laboratories, Inc. — Product Code JTA

K833917 is an FDA 510(k) premarket notification submitted by Marion Laboratories, Inc. for the device "BAC-T-SCREEN". 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. Marion Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1984
Date Received
November 14, 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 Marion Laboratories, Inc.

  • K883391 — POLYMER ADHESIVE BANDAGE (March 23, 1989)
  • K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN (July 5, 1988)
  • K875181 — MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM (May 27, 1988)
  • K874554 — ENVICLUSIVE (TM) (March 11, 1988)
  • K874551 — ENVINET(TM) (January 22, 1988)
  • K874552 — ENVISAN PAD (January 22, 1988)
  • K874553 — ENVISAN PASTE (December 18, 1987)
  • K870864 — CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST (April 14, 1987)
  • K863485 — MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST (September 17, 1986)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 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)
  • K842874 — RADIOMETRIC BLOOD CULTURE VIALS, AEROBE (September 12, 1984)
  • K842279 — BECTEC NR-660 BACTERIAL DETECT SYS (July 20, 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