Special Control Serum for Hdl-Choles
FDA 510(k) K823196 · Boehringer Mannheim Corp.
510(k) numberK823196
Submission
- Device name
- Special Control Serum for Hdl-Choles
- Applicant
- Boehringer Mannheim Corp.
Mchenry, IL, US - Received
- October 26, 1982
- Decision date
- November 29, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJK – Oncometer, Plasma, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2720
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K863099 | Abbott Testpack (TM) Acute Hep a Control KitJJK · Traditional | Abbott Laboratories | 09/16/1986SE |
| K802120 | Hepa-Shure -LJJK · Traditional | Nuclear Medical Laboratories, Inc. | 10/20/1980SE |
| K760975 | Weil Oncometer (Il 186)JJK · Traditional | Instrumentation Laboratory CO | 01/12/1977SE |
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| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Special Control Serum for Hdl-Choles cleared by the FDA?
Special Control Serum for Hdl-Choles (K823196) received a 510(k) decision of Substantially Equivalent on November 29, 1982, 34 days after the submission was received.
What is the product code of K823196?
The FDA product code is JJK – Oncometer, Plasma, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2720.