Ames Tda Amikacin Control Serum
FDA 510(k) K803107 · Miles Laboratories, Inc.
510(k) numberK803107
Submission
- Device name
- Ames Tda Amikacin Control Serum
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- December 10, 1980
- Decision date
- December 22, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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Questions and answers
When was Ames Tda Amikacin Control Serum cleared by the FDA?
Ames Tda Amikacin Control Serum (K803107) received a 510(k) decision of Substantially Equivalent on December 22, 1980, 12 days after the submission was received.
What is the product code of K803107?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.