FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NAT - NUCLEIC ACID TRANSPORT
K Number: K003761
·
Decision May 31, 2001
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
10
Review Days
176
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Basic Information
- Device Name
- NAT - NUCLEIC ACID TRANSPORT
- K Number
- K003761
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Packaging Corp.
- Date Received
- December 6, 2000
- Decision Date
- May 31, 2001
- 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 Medical Packaging Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K972726 | SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | Oct 8, 1997 | Substantially Equivalent |
| K970597 | CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION) | Mar 24, 1997 | Substantially Equivalent |
| K964637 | CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA | Dec 24, 1996 | Substantially Equivalent |
| K936078 | CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED | Aug 16, 1994 | Substantially Equivalent |
| K932337 | CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM | Aug 16, 1994 | Substantially Equivalent |
| K915454 | CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT | Apr 8, 1992 | Substantially Equivalent |
| K881105 | CULTURE COLLECTION DEVICE | Apr 25, 1988 | Substantially Equivalent |
| K870398 | PAP-PAK CYTOBRUSH KIT | Feb 25, 1987 | Substantially Equivalent |
| K864323 | CYTOLOGY BRUSHES | Jan 9, 1987 | Substantially Equivalent |