Apolipoprotien A-1 (Apo A-1)
FDA 510(k) K932606 · Sigma Diagnostics, Inc.
510(k) numberK932606
Submission
- Device name
- Apolipoprotien A-1 (Apo A-1)
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- May 28, 1993
- Decision date
- June 2, 1994
- 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 |
| K952466 | Olympus Apolipoprotein B Immunoturbidimetric ReagentJHN · Traditional | Olympus America, Inc. | 06/05/1995SE |
| K932603 | Apolipoprotien B (Apo B)JHN · Traditional | Sigma Diagnostics, Inc. | 06/02/1994SE |
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| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
| K013549 | Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971DAP · Traditional | 12/26/2001SE |
| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
| K013544 | Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096DAP · Traditional | 11/15/2001SE |
| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | 03/30/2001SE |
| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
Questions and answers
When was Apolipoprotien A-1 (Apo A-1) cleared by the FDA?
Apolipoprotien A-1 (Apo A-1) (K932606) received a 510(k) decision of Substantially Equivalent on June 2, 1994, 370 days after the submission was received.
What is the product code of K932606?
The FDA product code is JHN – Turbidimetric Method, Lipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.