Gelman Triphor Control
FDA 510(k) K850202 · Gelman Sciences, Inc.
510(k) numberK850202
Submission
- Device name
- Gelman Triphor Control
- Applicant
- Gelman Sciences, Inc.
Ann Arbor, MI, US - Received
- January 18, 1985
- Decision date
- February 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K941589 | Syringe Filter DevicesFMF · Traditional | 09/06/1994SE |
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| K942275 | Vial Vent FilterFPB · Traditional | 07/26/1994SE |
| K941032 | UnknownFMF · Traditional | 05/27/1994SE |
| K910821 | Transducer ProtectorFIB · Traditional | 08/12/1991SE |
| K892387 | Modified Gelman Arterial FilterDTM · Traditional | 06/22/1989SE |
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Questions and answers
When was Gelman Triphor Control cleared by the FDA?
Gelman Triphor Control (K850202) received a 510(k) decision of Substantially Equivalent on February 6, 1985, 19 days after the submission was received.
What is the product code of K850202?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.