FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
IAFP B.H.I. AGAR
K Number: K872677
·
Decision Aug 7, 1987
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
208
Applicant Total
29
Review Days
31
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Basic Information
- Device Name
- IAFP B.H.I. AGAR
- K Number
- K872677
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- I.A.F. Production, Inc.
- Date Received
- July 7, 1987
- Decision Date
- August 7, 1987
- Product Code
- JSG
- 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | FDA class 1 | Microbiology |
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Other Clearances by I.A.F. Production, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872690 | IAFP V. AGAR SELECTIVE | Sep 14, 1987 | Substantially Equivalent |
| K872676 | AFP MIDDLEBROOK 7H10 AGAR SLANT | Aug 11, 1987 | Substantially Equivalent |
| K872689 | IAFP SABOURAUD DEXTROSE AGAR | Aug 11, 1987 | Substantially Equivalent |
| K872691 | IAFP UREA AGAR SLANT | Aug 11, 1987 | Substantially Equivalent |
| K872685 | IAFP LOWENSTEIN JENSEN SLANT | Aug 11, 1987 | Substantially Equivalent |
| K872688 | IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD | Aug 11, 1987 | Substantially Equivalent |
| K872675 | IAFP MANNITOL NACL | Aug 11, 1987 | Substantially Equivalent |
| K872669 | IAFP X.L.D. AGAR | Aug 11, 1987 | Substantially Equivalent |
| K872683 | IAFP BILE ESCULIN AGAR | Aug 11, 1987 | Substantially Equivalent |
| K872672 | IAFP BILE ESCULIN AZIDE AGAR | Aug 11, 1987 | Substantially Equivalent |