Opticlone IGG1 FITC/IGG1 Pe Isotypic Control
FDA 510(k) K953498 · Immunotech, Inc.
510(k) numberK953498
Submission
- Device name
- Opticlone IGG1 FITC/IGG1 Pe Isotypic Control
- Applicant
- Immunotech, Inc.
Westbrook, ME, US - Received
- July 26, 1995
- Decision date
- September 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKZ – Counter, Differential Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
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More from Pixcell Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K954188 | Opticlone IGG1 FITC/IGG2A Pe Isotypic ControlGKZ · Traditional | 11/03/1995SE |
| K946335 | Opticlone(Tm CD3 FITC/CD19 Pe Monoclonal AntibodiesGKZ · Traditional | 10/20/1995SE |
| K952789 | Opticlone CD4FITC/CD8 Pe Monoclonal AntibodiesGKZ · Traditional | 08/14/1995SE |
| K952182 | Opticlone CD3/CD8 Monoclonal AntibodiesGKZ · Traditional | 07/05/1995SE |
| K950626 | Opticlone CD3/CD4 Monoclonal AntibodiesGKZ · Traditional | 05/05/1995SE |
| 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 |
| K905777 | Microzyme Thyroid Uptake Enzyme Immunoassay KitCEE · Traditional | 01/30/1991SE |
Questions and answers
When was Opticlone IGG1 FITC/IGG1 Pe Isotypic Control cleared by the FDA?
Opticlone IGG1 FITC/IGG1 Pe Isotypic Control (K953498) received a 510(k) decision of Substantially Equivalent on September 8, 1995, 44 days after the submission was received.
What is the product code of K953498?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.