FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIM - NITRATE TEST
K Number: K841270
·
Decision Apr 20, 1984
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
45
Review Days
24
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Basic Information
- Device Name
- RIM - NITRATE TEST
- K Number
- K841270
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Austin Biological Laboratories
- Date Received
- March 27, 1984
- Decision Date
- April 20, 1984
- Product Code
- JTO
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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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 |
| K860194 | AUSTIN ENTERIC SYSTEM | Feb 20, 1986 | Substantially Equivalent |
| K854577 | PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) | Feb 5, 1986 | Substantially Equivalent |
| K853772 | PRECEPT METHICILLIN | Sep 16, 1985 | Substantially Equivalent |