510(k) K023483
- Device
- KALAZAR DETECT
- Applicant
- INBIOS INTL., INC.
- 510(k) number
- K023483
- Product code
- LOO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-05-06
- Date received
- 2002-10-17
- Regulation
- 866.3870
- Classification name
- Reagent, Leishmanii Serological
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ESTELA I RAYCHAUDHURI
- Address
- 562 1st Ave. S, Suite 600 Seattle WA US 98104 98104
FDA Registration Numbers#
- 3011561946
- 2032682
- 3011527950
- 3032562
- 3022178699
- 3017013438
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LOO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842526 | AMIZYME-LEISHMANIA SPP. TEST KIT | Amico Lab, Inc. | 1984-08-28 |
Legacy Summary#
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FDA Review#
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