FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESP CULTURE SYSTEM - MYCO
K Number: K953129
·
Decision Dec 26, 1995
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
67
Applicant Total
121
Review Days
173
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ESP CULTURE SYSTEM - MYCO
- K Number
- K953129
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Difco Laboratories, Inc.
- Date Received
- July 6, 1995
- Decision Date
- December 26, 1995
- Product Code
- MDB
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDB | System, Blood Culturing | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MDB), ordered by most recent decision date.
BD BACTEC FXI Culture System
FDA 510(k)
FDA Class 1
·Microbiology
BD BACTEC Myco/F Lytic Culture Vials
FDA 510(k)
FDA Class 1
·Microbiology
BD BACTEC Plus Aerobic/F Culture Vials
FDA 510(k)
FDA Class 1
·Microbiology
BACT/ALERT MP Reagent System
FDA 510(k)
FDA Class 1
·Microbiology
BacT/ALERT FA Plus; BacT/ALERT PF Plus
FDA 510(k)
FDA Class 1
·Microbiology
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Difco Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971211 | DISPENS-O-DISC SPARFLOXACIN | Apr 14, 1997 | Substantially Equivalent |
| K971120 | DISPENS-O-DISC (TM) LEVOFLOXACIN | Apr 14, 1997 | Substantially Equivalent |
| K963508 | DISPENS-O-DISC MEROPENEM | Sep 26, 1996 | Substantially Equivalent |
| K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | Apr 26, 1996 | Substantially Equivalent |
| K954783 | DRYSLIDE CARTARRHALIS | Feb 6, 1996 | Substantially Equivalent |
| K954784 | DRYSIDE NEISSERIA | Jan 30, 1996 | Substantially Equivalent |
| K950706 | DRYSLIDE COAGULASE | May 16, 1995 | Substantially Equivalent |
| K944275 | DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. | Dec 19, 1994 | Substantially Equivalent |
| K941016 | DISPENS-O-DISC(TM) NITROCEFIN | Jun 30, 1994 | Substantially Equivalent |
| K934894 | CULTURESWAB TRANSPORT SYSTEM | Feb 22, 1994 | Substantially Equivalent |