FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIM-HAEMOPHILUS 2
K Number: K832239
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
45
Review Days
46
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Basic Information
- Device Name
- RIM-HAEMOPHILUS 2
- K Number
- K832239
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Austin Biological Laboratories
- Date Received
- June 27, 1983
- Decision Date
- August 12, 1983
- Product Code
- JST
- 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 |
|---|---|---|---|
| JST | Kit, Fastidious Organisms | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JST), ordered by most recent decision date.
BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM
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API 50 CHB (CULTURE MEDIA)
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SYNTHETIC BROTH A.O.A.C.
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RIM-HAEMOPHILUS 1 & 2
FDA 510(k)
FDA Class 1
·Microbiology
STREPTOCOCUS ID PLATE
FDA 510(k)
FDA Class 1
·Microbiology
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 |