Profile Cardiac Set Assayed Serum Contr.
FDA 510(k) K803036 · General Diagnostics
510(k) numberK803036
Submission
- Device name
- Profile Cardiac Set Assayed Serum Contr.
- Applicant
- General Diagnostics
Mchenry, IL, US - Received
- December 1, 1980
- Decision date
- December 22, 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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| K863877 | Benzodiazepine Enzyme Immunoassay KitJXM · Traditional | 03/12/1987SE |
| K842307 | General Diag. Cefonicid 30MCG AntimicJTN · Traditional | 07/20/1984SE |
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| K833709 | Ceftizoxime 30 MCG Antimicrobial DiskJTN · Traditional | 12/30/1983SE |
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| K831179 | Cefazolin 30MCG. Antimicrobial SuscepJTN · Traditional | 05/09/1983SE |
Questions and answers
When was Profile Cardiac Set Assayed Serum Contr. cleared by the FDA?
Profile Cardiac Set Assayed Serum Contr. (K803036) received a 510(k) decision of Substantially Equivalent on December 22, 1980, 21 days after the submission was received.
What is the product code of K803036?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.