510(k) K021648
- Device
- QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
- Applicant
- INOVA DIAGNOSTICS, INC.
- 510(k) number
- K021648
- Product code
- NJF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-09-20
- Date received
- 2002-05-20
- Regulation
- 866.5120
- Classification name
- Antibodies, Anti-actin, Anti-smooth Muscle
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRYS C MYERS
- Address
- 10180 Scripps Ranch Blvd. San Diego CA US 92131 92131
FDA Registration Numbers#
- 2026994
- 3012348571
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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