FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
K Number: K051638
·
Decision Dec 6, 2005
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
43
Applicant Total
73
Review Days
169
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
- K Number
- K051638
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unipath , Ltd.
- Date Received
- June 20, 2005
- Decision Date
- December 6, 2005
- Product Code
- GTY
- 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 |
|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GTY), ordered by most recent decision date.
AllTest Strep A Rapid Test
FDA 510(k)
FDA Class 1
·Microbiology
Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
FDA 510(k)
FDA Class 1
·Microbiology
Healgen Strep A Rapid Test Strip (Throat Swab)
FDA 510(k)
FDA Class 1
·Microbiology
Sofia Strep A+ FIA, Sofia 2 Analyzer
FDA 510(k)
FDA Class 1
·Microbiology
SOFIA (R) STREP A+ FIA
FDA 510(k)
FDA Class 1
·Microbiology
WONDFO RAPID STREP A TEST
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Unipath , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K061769 | E.P.T. CERTAINTY 1-STEP PREGNANCY TEST | Jul 3, 2006 | Substantially Equivalent |
| K060128 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | May 25, 2006 | Substantially Equivalent |
| K050930 | E.P.T. CERTAINTY PREGNANCY TEST | May 12, 2005 | Substantially Equivalent |
| K042280 | FACT PLUS ONE-STEP PREGNANCY TEST KIT | Sep 10, 2004 | Substantially Equivalent |
| K041404 | CLEARBLUE EASY EASY READ PREGNANCY TEST | Jun 8, 2004 | Substantially Equivalent |
| K040341 | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST | Mar 8, 2004 | Substantially Equivalent |
| K040329 | MODIFICATION TO E.P.T. PREGNANCY TEST | Mar 8, 2004 | Substantially Equivalent |
| K033658 | E.P.T. PREGNANCY TEST | Jan 16, 2004 | Substantially Equivalent |
| K032939 | EPT CERTAINTY PREGNANCY TEST | Oct 20, 2003 | Substantially Equivalent |
| K030659 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | May 2, 2003 | Substantially Equivalent |