In Vitro Diagnostic Standards
FDA 510(k) K802278 · Supelco, Inc.
510(k) numberK802278
Submission
- Device name
- In Vitro Diagnostic Standards
- Applicant
- Supelco, Inc.
Mchenry, IL, US - Received
- September 12, 1980
- Decision date
- November 24, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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| K881361 | Solid Phase Extraction TubesDJY · Traditional | 08/08/1988SE |
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| K874824 | Capillary Columns for Gas ChromatographyDII · Traditional | 01/21/1988SE |
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| K862542 | Capillary Columns for Gas ChromatographyDII · Traditional | 08/04/1986SE |
| K862541 | Liquid Chromatography ColumnsDPM · Traditional | 07/29/1986SE |
Questions and answers
When was In Vitro Diagnostic Standards cleared by the FDA?
In Vitro Diagnostic Standards (K802278) received a 510(k) decision of Substantially Equivalent on November 24, 1980, 73 days after the submission was received.
What is the product code of K802278?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.