Captia Cmv-Ta
FDA 510(k) K915479 · Mercia Diagnostics , Ltd.
510(k) numberK915479
Submission
- Device name
- Captia Cmv-Ta
- Applicant
- Mercia Diagnostics , Ltd.
Guildford, Surrey England, GB - Received
- December 6, 1991
- Decision date
- May 4, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
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More from Quest Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K904524 | Captia(R) Syphilis M, ModificationLIP · Traditional | 12/26/1990SE |
| K900654 | Modified Captia(R) Syphilis-MLIP · Traditional | 03/08/1990SE |
| K900655 | Modified Captia(R) Toxo-MLGD · Traditional | 03/06/1990SE |
| K896295 | Captia(R) Cmv-MLFZ · Traditional | 03/06/1990SE |
| K896194 | Captia(R) Cmv-GLFZ · Traditional | 03/06/1990SE |
| K885300 | Captia(R) Rubella-MLFX · Traditional | 08/15/1989SE |
| K883924 | Captia(R) Rubella-GLFX · Traditional | 08/15/1989SE |
| K892802 | Super DuoJWZ · Traditional | 06/13/1989SE |
| K881425 | Captia(R) Syphilis-GLIP · Traditional | 08/04/1988SE |
| K880918 | Captia Toxo-GLGD · Traditional | 08/01/1988SE |
Questions and answers
When was Captia Cmv-Ta cleared by the FDA?
Captia Cmv-Ta (K915479) received a 510(k) decision of Substantially Equivalent on May 4, 1992, 150 days after the submission was received.
What is the product code of K915479?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.