FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG
K Number: K843065
·
Decision Aug 20, 1984
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
50
Applicant Total
98
Review Days
14
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Basic Information
- Device Name
- BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG
- K Number
- K843065
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2330
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Otisville Biotech, Inc.
- Date Received
- August 6, 1984
- Decision Date
- August 20, 1984
- 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.
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WALLENSTEIN MEDIUM SLANT
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Other Clearances by Otisville Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862397 | BIOTIS DECARBOXYLASE MEDIA, LYSINE | Jul 3, 1986 | Substantially Equivalent |
| K862389 | BIOTIS ACETAMIDE AGAR | Jul 3, 1986 | Substantially Equivalent |
| K862393 | BIOTIS LITMUS MILK | Jul 3, 1986 | Substantially Equivalent |
| K862392 | BIOTIS MOTILITY TEST MEDIUM | Jul 3, 1986 | Substantially Equivalent |
| K862395 | BIOTIS DECARBOXYLASE MEDIA, BASE | Jul 3, 1986 | Substantially Equivalent |
| K862388 | BIOTIS TCBS AGAR | Jul 3, 1986 | Substantially Equivalent |
| K862399 | BIOTIS SXT AGAR | Jul 3, 1986 | Substantially Equivalent |
| K862396 | BIOTIS DECARBOXYLASE MEDIA, ARGININE | Jul 3, 1986 | Substantially Equivalent |
| K862387 | BIOTIS HAEMOPHILUS IDENTIFICATION QUAD | Jul 3, 1986 | Substantially Equivalent |
| K862394 | BIOTIS MITIS SALIVARIUS | Jul 3, 1986 | Substantially Equivalent |