FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANATON
K Number: K801046
·
Decision May 14, 1980
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
68
Review Days
9
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ANATON
- K Number
- K801046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Armkel, LLC
- Date Received
- May 5, 1980
- Decision Date
- May 14, 1980
- Product Code
- DHN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHN), ordered by most recent decision date.
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
FDA 510(k)
FDA Class 2
·Immunology
ImmuGlo HEp-2 Elite IFA
FDA 510(k)
FDA Class 2
·Immunology
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Image Navigator by Immuno Concepts
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
FDA 510(k)
FDA Class 2
·Immunology
NOVA Lite DAPI ANA Kit
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Armkel, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K040866 | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST | Oct 19, 2004 | Substantially Equivalent |
| K030258 | FIRST RESPONSE PREGNANCY TEST | Feb 25, 2003 | Substantially Equivalent |
| K023405 | TROJAN MINT TINGLE BRAND LATEX CONDOMS | Dec 16, 2002 | Substantially Equivalent |
| K013433 | TROJAN PASSION BERRY GEL | Mar 5, 2002 | Substantially Equivalent |
| K013614 | TROJAN CRYSTAL CLEAR LIQUID | Feb 1, 2002 | Substantially Equivalent |
| K001212 | TROJAN EXTRA LARGE LATEX CONDOM | May 9, 2000 | Substantially Equivalent |
| K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | Apr 6, 2000 | Substantially Equivalent |
| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | Dec 21, 1999 | Substantially Equivalent |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Oct 27, 1997 | Substantially Equivalent |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Oct 27, 1997 | Substantially Equivalent |