Inverness Medical Testpack + Plus Strep a with Obc
FDA 510(k) K051638 · Unipath , Ltd.
510(k) numberK051638
Submission
- Device name
- Inverness Medical Testpack + Plus Strep a with Obc
- Applicant
- Unipath , Ltd.
Bedford, GB - Received
- June 20, 2005
- Decision date
- December 6, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GTY – Antigens, All Groups, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
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| K123793 | Sofia Strep a FiaGTY · Traditional | Quidel Corporation | 06/17/2013SE |
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Questions and answers
When was Inverness Medical Testpack + Plus Strep a with Obc cleared by the FDA?
Inverness Medical Testpack + Plus Strep a with Obc (K051638) received a 510(k) decision of Substantially Equivalent on December 6, 2005, 169 days after the submission was received.
What is the product code of K051638?
The FDA product code is GTY – Antigens, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.