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510(k) K953129

ESP CULTURE SYSTEM - MYCO by Difco Laboratories, Inc. — Product Code MDB

K953129 is an FDA 510(k) premarket notification submitted by Difco Laboratories, Inc. for the device "ESP CULTURE SYSTEM - MYCO". The FDA issued a decision of Substantially Equivalent on December 26, 1995. The device falls under product code MDB (System, Blood Culturing), a Class I device regulated under 21 CFR 866.2560. Difco Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1995
Date Received
July 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood Culturing
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type

Other clearances by Difco Laboratories, Inc.

  • K971120 — DISPENS-O-DISC (TM) LEVOFLOXACIN (April 14, 1997)
  • K971211 — DISPENS-O-DISC SPARFLOXACIN (April 14, 1997)
  • K963508 — DISPENS-O-DISC MEROPENEM (September 26, 1996)
  • K961148 — CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) (April 26, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)
  • K954784 — DRYSIDE NEISSERIA (January 30, 1996)
  • K950706 — DRYSLIDE COAGULASE (May 16, 1995)
  • K944275 — DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. (December 19, 1994)
  • K941016 — DISPENS-O-DISC(TM) NITROCEFIN (June 30, 1994)
  • K934894 — CULTURESWAB TRANSPORT SYSTEM (February 22, 1994)

Other clearances for product code MDB

  • K260213 — BD BACTEC FXI Culture System (May 28, 2026)
  • K222559 — BD BACTEC™ Myco/F Lytic Culture Vials (March 24, 2023)
  • K222591 — BD BACTEC™ Plus Aerobic/F Culture Vials (March 24, 2023)
  • K190405 — BACT/ALERT MP Reagent System (May 15, 2019)
  • K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus (February 11, 2019)
  • K173873 — BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a (March 16, 2018)
  • K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (March 28, 2017)
  • K161810 — BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a P (February 9, 2017)
  • K161306 — BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Pl (August 8, 2016)
  • K151866 — BD BACTEC Peds Plus/F Culture Vials (plastic) (February 25, 2016)

FDA data resources