Olympus Apolipoprotein B Immunoturbidimetric Reagent
FDA 510(k) K952466 · Olympus America, Inc.
510(k) numberK952466
Submission
- Device name
- Olympus Apolipoprotein B Immunoturbidimetric Reagent
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- May 26, 1995
- Decision date
- June 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JHN – Turbidimetric Method, Lipoproteins
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950383 | Apolipoprotein A-I Immunoturbidimetric KitJHN · Traditional | Randox Laboratories, Ltd. | 09/15/1995SE |
| K950382 | Apolipoprotein B Immunoturbidiemetric KitJHN · Traditional | Randox Laboratories, Ltd. | 09/15/1995SE |
| K952615 | Wako Autokit Apo A1JHN · Traditional | Wako Chemicals USA, Inc. | 09/08/1995SE |
| K952425 | Olympus Apolipoprotein A1 Immunoturbidimetric ReagentJHN · Traditional | Olympus America, Inc. | 07/05/1995SE |
| K932606 | Apolipoprotien A-1 (Apo A-1)JHN · Traditional | Sigma Diagnostics, Inc. | 06/02/1994SE |
| K932603 | Apolipoprotien B (Apo B)JHN · Traditional | Sigma Diagnostics, Inc. | 06/02/1994SE |
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Questions and answers
When was Olympus Apolipoprotein B Immunoturbidimetric Reagent cleared by the FDA?
Olympus Apolipoprotein B Immunoturbidimetric Reagent (K952466) received a 510(k) decision of Substantially Equivalent on June 5, 1995, 10 days after the submission was received.
What is the product code of K952466?
The FDA product code is JHN – Turbidimetric Method, Lipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.