Cholesterol Chod-Pap Test
FDA 510(k) K823302 · Boehringer Mannheim Corp.
510(k) numberK823302
Submission
- Device name
- Cholesterol Chod-Pap Test
- Applicant
- Boehringer Mannheim Corp.
Mchenry, IL, US - Received
- November 5, 1982
- Decision date
- December 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
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| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
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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 |
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Questions and answers
When was Cholesterol Chod-Pap Test cleared by the FDA?
Cholesterol Chod-Pap Test (K823302) received a 510(k) decision of Substantially Equivalent on December 9, 1982, 34 days after the submission was received.
What is the product code of K823302?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.