American Histo-Id Sys Primary Kit Psa Prostate Ant
FDA 510(k) K855034 · Bartels Immunodiagnostic Supplies, Inc.
510(k) numberK855034
Submission
- Device name
- American Histo-Id Sys Primary Kit Psa Prostate Ant
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
Bellevue, WA, US - Received
- December 17, 1985
- Decision date
- March 11, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code LIJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K820336 | Dako Pap Kit K509LIJ · Traditional | Dako Corp. | 07/13/1982SE |
More from Dako Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K864776 | A549 (Human Lung Carcinoma) Culture CellsKIR · Traditional | 12/31/1986SE |
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| K860279 | Cytomegalovirus Direct Fluorescent Antibody KitLIN · Traditional | 05/13/1986SE |
| K842830 | Immunoper-Oxidase Test Kit for Detect ofGQN · Traditional | 11/26/1985SE |
| K852185 | Respiratory Syncytial Virus Direct Fluorescent AntLKT · Traditional | 08/19/1985SE |
| K844105 | Fitc Labeled Chlamydiae Monoclonal Antibody · Traditional | 12/06/1984SE |
| K842834 | HEP-2 CellsKJR · Traditional | 08/28/1984SE |
| K842833 | PMK Primary Monkey Kidney-CellsKJR · Traditional | 08/28/1984SE |
| K842328 | Amer. Histo-Id Sys Primary Lambda ChainDEH · Traditional | 08/03/1984SE |
| K842330 | Amer. Histo-Id Sys Primary Iga 2720-21CZP · Traditional | 08/02/1984SE |
Questions and answers
When was American Histo-Id Sys Primary Kit Psa Prostate Ant cleared by the FDA?
American Histo-Id Sys Primary Kit Psa Prostate Ant (K855034) received a 510(k) decision of Substantially Equivalent on March 11, 1986, 84 days after the submission was received.
What is the product code of K855034?
The FDA product code is LIJ – Peroxidase Anti-Peroxidase Immunohistochemical Stain, a Class I (low risk) device regulated under 21 CFR 864.4400.