510(k) K812741
- Device
- REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
- Applicant
- NOLAN BIOLOGICAL LABORATORIES, INC.
- 510(k) number
- K812741
- Product code
- LHK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-10-23
- Date received
- 1981-09-29
- Regulation
- 866.3165
- Classification name
- Antigen, Id, Candida Albicans
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3005360469
- 3024463179
- 3016837106
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LHK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K893753 | DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-16 |
| K823016 | CANDIDA DETECTION SYSTEM | Ramco Laboratories, Inc. | 1982-12-28 |
| K812186 | CANDIDA IMMUNODIFFUSION SYSTEM | American Scientific Products | 1981-08-25 |
Legacy Summary#
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FDA Review#
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