Synelisa Cenp-B Antibodies
FDA 510(k) K931255 · Elias U.S.A., Inc.
510(k) numberK931255
Submission
- Device name
- Synelisa Cenp-B Antibodies
- Applicant
- Elias U.S.A., Inc.
Osceola, WI, US - Received
- March 12, 1993
- Decision date
- September 24, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K024218 | Liquichek Anti-Ss-A Control, Positive, Catalog #114LKJ · Traditional | Bio-Rad | 01/17/2003SE |
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Questions and answers
When was Synelisa Cenp-B Antibodies cleared by the FDA?
Synelisa Cenp-B Antibodies (K931255) received a 510(k) decision of Substantially Equivalent on September 24, 1993, 196 days after the submission was received.
What is the product code of K931255?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.