Beckman Array Tobramycin (Tob) Reagent
FDA 510(k) K952568 · Beckman Instruments, Inc.
510(k) numberK952568
Submission
- Device name
- Beckman Array Tobramycin (Tob) Reagent
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- June 5, 1995
- Decision date
- August 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCR – Fluorescent Immunoassay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Specialty
- Clinical Toxicology
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Questions and answers
When was Beckman Array Tobramycin (Tob) Reagent cleared by the FDA?
Beckman Array Tobramycin (Tob) Reagent (K952568) received a 510(k) decision of Substantially Equivalent on August 8, 1995, 64 days after the submission was received.
What is the product code of K952568?
The FDA product code is LCR – Fluorescent Immunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.