No. 1000-H for Immunofluorometric Deter. of (Ana)
FDA 510(k) K874115 · Sigma Diagnostics, Inc.
510(k) numberK874115
Submission
- Device name
- No. 1000-H for Immunofluorometric Deter. of (Ana)
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- October 9, 1987
- Decision date
- November 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K034013 | Reaads Dsdna Quantitative Test Kit, Model 022-001LKJ · Special | Corgenix, Inc. | 01/08/2004SE |
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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 No. 1000-H for Immunofluorometric Deter. of (Ana) cleared by the FDA?
No. 1000-H for Immunofluorometric Deter. of (Ana) (K874115) received a 510(k) decision of Substantially Equivalent on November 4, 1987, 26 days after the submission was received.
What is the product code of K874115?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.