FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ECG BASED MEDIA
K Number: K873267
·
Decision Nov 4, 1987
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
50
Applicant Total
14
Review Days
85
Basic Information
- Device Name
- ECG BASED MEDIA
- K Number
- K873267
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2330
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- CENTRAL MEDIA
- Date Received
- August 11, 1987
- Decision Date
- November 4, 1987
- Product Code
- KZI
- 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 |
|---|---|---|---|
| KZI | Culture Media, Enriched | FDA class 1 | Microbiology |
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Other Clearances by CENTRAL MEDIA
| K Number | Device Name | ||
|---|---|---|---|
| K873260 | CORYNEBACTERIA ISOLATION MEDIA | Nov 6, 1987 | Substantially Equivalent |
| K873257 | GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA. | Nov 6, 1987 | Substantially Equivalent |
| K873259 | SPECIALTY MEDIA | Nov 6, 1987 | Substantially Equivalent |
| K873258 | STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA | Nov 6, 1987 | Substantially Equivalent |
| K873269 | MYCOLOGICAL MEDIA | Nov 4, 1987 | Substantially Equivalent |
| K873270 | ACTINOMYCETE DIFFERENTIAL MEDIA | Nov 4, 1987 | Substantially Equivalent |
| K873268 | MUELLER HINTON MEDIA | Nov 4, 1987 | Substantially Equivalent |
| K873264 | MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS | Oct 28, 1987 | Substantially Equivalent |
| K873263 | MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA | Oct 28, 1987 | Substantially Equivalent |
| K873261 | ENTERIC ISOLATION MEDIA | Oct 28, 1987 | Substantially Equivalent |