ANATON
FDA 510(k) clearance K801046 · decided 1980-05-14
Clearance details
- K-number
- K801046
- Device name
- ANATON
- Applicant
- Armkel, LLC
- Decision
- Substantially Equivalent
- Date received
- 1980-05-05
- Decision date
- 1980-05-14
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- DHN
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Zeus IFA ANA HEp-2 Test System, Zeus dIFine (K201956) | Zeus Scientific, Inc. | 2022-04-29 |
| ImmuGlo HEp-2 Elite IFA (K172745) | Immco Diagnostics, Inc. | 2018-06-05 |
| AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM (K153117) | Aesku Systems GmbH&Co.Kg | 2016-07-28 |
| Image Navigator by Immuno Concepts (K160265) | Immuno Concepts, N.A. , Ltd. | 2016-06-17 |
| EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (K141827) | Euroimmun Us, Inc. | 2015-04-17 |
| NOVA Lite DAPI ANA Kit (K150155) | Inova Diagnostics, Inc. | 2015-04-08 |
| IFA 40: HEP-20-10 (K131791) | Euroimmun US | 2014-02-26 |
| AESKUSLIDES ANA HEP-2 (K120889) | Aesku Diagnostics | 2012-10-15 |
| EUROIMMUN ANA IFA: HEP-20-10 (K070763) | Euroimmun Us, LLC | 2007-05-22 |
| RHIGENE HEP-ANA TEST SYSTEM (K042680) | Corgenix, Inc. | 2004-11-19 |
| LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 (K024220) | Bio-Rad | 2003-01-17 |
| LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 (K024222) | Bio-Rad | 2003-01-15 |
Recalls involving this device
No recalls on record reference this clearance.