Active LH Irma
FDA 510(k) K961109 · Diagnostic Systems Laboratories, Inc.
510(k) numberK961109
Submission
- Device name
- Active LH Irma
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- March 20, 1996
- Decision date
- April 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEP – Radioimmunoassay, Luteinizing Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Specialty
- Clinical Chemistry
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| K973244 | Active Psa Irma (DSL-9700)LTJ · Traditional | 08/03/1998SE |
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Questions and answers
When was Active LH Irma cleared by the FDA?
Active LH Irma (K961109) received a 510(k) decision of Substantially Equivalent on April 5, 1996, 16 days after the submission was received.
What is the product code of K961109?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.