FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUSTIN ENTERIC SYSTEM
K Number: K860194
·
Decision Feb 20, 1986
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
52
Applicant Total
45
Review Days
29
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Basic Information
- Device Name
- AUSTIN ENTERIC SYSTEM
- K Number
- K860194
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Austin Biological Laboratories
- Date Received
- January 22, 1986
- Decision Date
- February 20, 1986
- Product Code
- JSE
- 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 |
|---|---|---|---|
| JSE | Culture Media, Multiple Biochemical Test | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSE), ordered by most recent decision date.
MLX MICROTITER PLATE LUMINOMETER
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KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
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FDA Class 1
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Other Clearances by Austin Biological Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K880511 | XACT NEISSERIA | Aug 25, 1988 | Substantially Equivalent |
| K874727 | PRECEPT(TM) CIPROFLOXACIN | Feb 18, 1988 | Substantially Equivalent |
| K870769 | AUSTIN NONFERMENTER KIT | Apr 3, 1987 | Substantially Equivalent |
| K864069 | PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID | Nov 13, 1986 | Substantially Equivalent |
| K862560 | PRECEPT CEFTIZOXIME | Jul 11, 1986 | Substantially Equivalent |
| K862446 | PRECEPT CEFTAZIDIME | Jul 11, 1986 | Substantially Equivalent |
| K860195 | PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE | Feb 20, 1986 | Substantially Equivalent |
| K854577 | PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) | Feb 5, 1986 | Substantially Equivalent |
| K853772 | PRECEPT METHICILLIN | Sep 16, 1985 | Substantially Equivalent |
| K853596 | PRECEPT CEFOPERAZONE | Sep 16, 1985 | Substantially Equivalent |