FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
CHOCOLATE AGAR
K Number: K864238
·
Decision Mar 31, 1987
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
50
Applicant Total
21
Review Days
154
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Basic Information
- Device Name
- CHOCOLATE AGAR
- K Number
- K864238
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2330
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Mds Laboratories, Inc.
- Date Received
- October 28, 1986
- Decision Date
- March 31, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZI), ordered by most recent decision date.
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
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DIAMOND'S MEDIUM MODIFIED
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LOWENSTEIN-JENSEN, GRUFT
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MIDDLEBROOK 7H11 AGAR
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FDA Class 1
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MIDDLEBROOK 7H9 BROTH
FDA 510(k)
FDA Class 1
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WALLENSTEIN MEDIUM SLANT
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Mds Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864251 | SELENITE F. BROTH | Mar 31, 1987 | Substantially Equivalent |
| K864255 | TRYPTICASE SOY BROTH | Mar 31, 1987 | Substantially Equivalent |
| K864240 | COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD | Mar 31, 1987 | Substantially Equivalent |
| K864241 | DNASE AGAR | Mar 31, 1987 | Substantially Equivalent |
| K864244 | GARNERELLA VAGINALIS IDENTIFICATION KIT | Mar 31, 1987 | Substantially Equivalent |
| K864239 | CLED AGAR WITH ANDRADES INDICATOR | Mar 31, 1987 | Substantially Equivalent |
| K864254 | THIOGLYCOLLATE BROTH | Mar 31, 1987 | Substantially Equivalent |
| K864237 | CARY BLAIR TRANSPORT MEDIUM | Mar 31, 1987 | Substantially Equivalent |
| K864246 | MUELLER HINTON AGAR LARGE | Mar 31, 1987 | Substantially Equivalent |
| K864249 | NORMAL SALINE STERILE | Mar 31, 1987 | Substantially Equivalent |