Amerlite FSH Assay
FDA 510(k) K952285 · Johnson & Johnson Clinical Diagnostics, Inc.
510(k) numberK952285
Submission
- Device name
- Amerlite FSH Assay
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- May 16, 1995
- Decision date
- July 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGJ – Radioimmunoassay, Follicle-Stimulating Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1300
- Specialty
- Clinical Chemistry
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| K964693 | Elecsys FSH AssayCGJ · Traditional | Boehringer Mannheim Corp. | 12/16/1996SE |
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Questions and answers
When was Amerlite FSH Assay cleared by the FDA?
Amerlite FSH Assay (K952285) received a 510(k) decision of Substantially Equivalent on July 3, 1995, 48 days after the submission was received.
What is the product code of K952285?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.