Seralyzer Drug Assay Control Serum
FDA 510(k) K833977 · Miles Laboratories, Inc.
510(k) numberK833977
Submission
- Device name
- Seralyzer Drug Assay Control Serum
- Applicant
- Miles Laboratories, Inc.
Walker, MI, US - Received
- November 17, 1983
- Decision date
- March 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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| 510(k) | Device | Decision |
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| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
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| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
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Questions and answers
When was Seralyzer Drug Assay Control Serum cleared by the FDA?
Seralyzer Drug Assay Control Serum (K833977) received a 510(k) decision of Substantially Equivalent on March 19, 1984, 123 days after the submission was received.
What is the product code of K833977?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.