FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CYTOQUANT COMBINED TRANSPORT MEDIA
K Number: K924053
·
Decision Jan 15, 1993
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
54
Review Days
156
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Basic Information
- Device Name
- CYTOQUANT COMBINED TRANSPORT MEDIA
- K Number
- K924053
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Proteins Intl., Inc.
- Date Received
- August 12, 1992
- Decision Date
- January 15, 1993
- Product Code
- LIO
- 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 |
|---|---|---|---|
| LIO | Device, Specimen Collection | FDA class 1 | Microbiology |
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Other Clearances by Proteins Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961756 | CYTOQUANT VIRAL TRANSPORT MEDIUM | May 17, 1996 | Substantially Equivalent |
| K961755 | CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM | May 17, 1996 | Substantially Equivalent |
| K930390 | 25 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-291 | Mar 24, 1993 | Substantially Equivalent |
| K930396 | 16 X 125 MM TEST TUBE, CATALOG #01-291 | Mar 24, 1993 | Substantially Equivalent |
| K930393 | ONE DRAM SHELL VIAL, CATALOG #02-261 | Mar 24, 1993 | Substantially Equivalent |
| K930397 | 16 X 125 MM TEST TUBE, CATALOG | Mar 24, 1993 | Substantially Equivalent |
| K930395 | ONE DRAM SHELL VIAL, CATALOG #02-461 | Mar 24, 1993 | Substantially Equivalent |
| K930392 | 16 X 125 MM TEST TUBE, CATALOG #01-111 | Mar 24, 1993 | Substantially Equivalent |
| K930391 | 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261 | Mar 24, 1993 | Substantially Equivalent |
| K930394 | 25 CM2, 75 CM2, A50 CM2 FLASK, CATALOG #03-211 | Mar 24, 1993 | Substantially Equivalent |