Cobas Core LH Eia
FDA 510(k) K930306 · Roche Diagnostic Systems, Inc.
510(k) numberK930306
Submission
- Device name
- Cobas Core LH Eia
- Applicant
- Roche Diagnostic Systems, Inc.
Branchburg, NJ, US - Received
- January 21, 1993
- Decision date
- May 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
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Questions and answers
When was Cobas Core LH Eia cleared by the FDA?
Cobas Core LH Eia (K930306) received a 510(k) decision of Substantially Equivalent on May 26, 1993, 125 days after the submission was received.
What is the product code of K930306?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.