TDXR Multiconstit. Controls for Abused Drug Assays
FDA 510(k) K873183 · Abbott Laboratories
510(k) numberK873183
Submission
- Device name
- TDXR Multiconstit. Controls for Abused Drug Assays
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 12, 1987
- Decision date
- November 23, 1987
- 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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| K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000…DIF · Abbreviated | Roche Diagnostics Corp. | 03/25/2008SE |
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Questions and answers
When was TDXR Multiconstit. Controls for Abused Drug Assays cleared by the FDA?
TDXR Multiconstit. Controls for Abused Drug Assays (K873183) received a 510(k) decision of Substantially Equivalent on November 23, 1987, 103 days after the submission was received.
What is the product code of K873183?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.