Microzyme(Tm) Methamphet/Amphet Enzyme Immuno Kit
FDA 510(k) K903993 · Immunotech Corp.
510(k) numberK903993
Submission
- Device name
- Microzyme(Tm) Methamphet/Amphet Enzyme Immuno Kit
- Applicant
- Immunotech Corp.
Boston, MA, US - Received
- August 29, 1990
- Decision date
- December 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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| K954188 | Opticlone IGG1 FITC/IGG2A Pe Isotypic ControlGKZ · Traditional | 11/03/1995SE |
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| K953498 | Opticlone IGG1 FITC/IGG1 Pe Isotypic ControlGKZ · Traditional | 09/08/1995SE |
| K952789 | Opticlone CD4FITC/CD8 Pe Monoclonal AntibodiesGKZ · Traditional | 08/14/1995SE |
| K952182 | Opticlone CD3/CD8 Monoclonal AntibodiesGKZ · Traditional | 07/05/1995SE |
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| K931228 | Progesterone Radioimmunoassay KitJLS · Traditional | 10/22/1993SE |
| K911634 | Microzyme(Tm) Free T4 Enzyme Immunoassay TestCEC · Traditional | 06/24/1991SE |
| K911153 | Microzyme Phencyclidine Enzyme Immunoassay Test KTLCM · Traditional | 06/18/1991SE |
| K910411 | Microzyme TSH Enzyme Immunoassay KitJLW · Traditional | 04/03/1991SE |
Questions and answers
When was Microzyme(Tm) Methamphet/Amphet Enzyme Immuno Kit cleared by the FDA?
Microzyme(Tm) Methamphet/Amphet Enzyme Immuno Kit (K903993) received a 510(k) decision of Substantially Equivalent on December 20, 1990, 113 days after the submission was received.
What is the product code of K903993?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.