FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TESTCORP ANA
K Number: K831365
·
Decision Jun 2, 1983
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
12
Applicant Total
13
Review Days
37
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Basic Information
- Device Name
- TESTCORP ANA
- K Number
- K831365
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Catheter Technology Corp.
- Date Received
- April 26, 1983
- Decision Date
- June 2, 1983
- Product Code
- LKS
- 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 |
|---|---|---|---|
| LKS | Device, Parasite Concentration | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKS), ordered by most recent decision date.
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PARA-PAK SPINCON
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PARAKIT
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CON-KIT
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STOOL TRANSPORT/PROCESSOR
FDA 510(k)
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Other Clearances by Catheter Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880571 | CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM | Mar 4, 1988 | Substantially Equivalent |
| K871080 | PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | Aug 12, 1987 | Substantially Equivalent |
| K871998 | GROSHONG CV CATHETER REPAIR KIT | Jun 24, 1987 | Substantially Equivalent |
| K860256 | BRAWN AND GROSHONG CATHETERS | Mar 28, 1986 | Substantially Equivalent |
| K842577 | CATH-TECH POLYURETHANE UMBILICAL VESS | Mar 13, 1985 | Substantially Equivalent |
| K842147 | CATH-TECH CHOLANGIOGRAPHY CATHETER | Oct 2, 1984 | Substantially Equivalent |
| K840339 | UMBILICAL VESSEL CATHETER | Jul 25, 1984 | Substantially Equivalent |
| K831386 | GROSHONG CATHETER, LONG TERM TYPE | Oct 14, 1983 | Substantially Equivalent |
| K831366 | TESTCORP PREG | Jun 2, 1983 | Substantially Equivalent |
| K831361 | BETA-PREG | Jun 2, 1983 | Substantially Equivalent |