Syncor Trich Direct Immunofluorescence Assay
FDA 510(k) K852665 · Syncor Intl. Corp.
510(k) numberK852665
Submission
- Device name
- Syncor Trich Direct Immunofluorescence Assay
- Applicant
- Syncor Intl. Corp.
Berkeley, CA, US - Received
- June 24, 1985
- Decision date
- August 13, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JWZ – Kit, Screening, Trichomonas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K033864 | Genzyme Osom Trichomonas Rapid TestJWZ · Traditional | Genzyme Corp. | 04/02/2004SE |
| K020595 | Xenostrip-Tv Trichomonas Cassette Test, Model C1383.01JWZ · Traditional | Xenotope Diagnostics, Inc. | 02/20/2003SE |
| K020226 | Xenostrip-Tv Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 &…JWZ · Traditional | Hellen Professional Services | 08/22/2002SE |
| K894246 | Meriview TM TrichomonasJWZ · Traditional | Meridian Diagnostics, Inc. | 08/15/1989SE |
| K892802 | Super DuoJWZ · Traditional | Mercia Diagnostics , Ltd. | 06/13/1989SE |
| K892263 | Merifluor(Tm) -TrichomonasJWZ · Traditional | Meridian Diagnostics, Inc. | 05/24/1989SE |
| K875138 | Trichomate(R) SuperJWZ · Traditional | Mercia Diagnostics , Ltd. | 05/13/1988SE |
| K874259 | Trichomonas Direct Enzyme ImmunoassayJWZ · Traditional | California Integrated Diagnostics, Inc. | 12/07/1987SE |
| K871279 | Modified Trichomonas Direct Specimen Test KitJWZ · Traditional | California Integrated Diagnostics, Inc. | 04/08/1987SE |
| K830497 | Pem-TJWZ · Traditional | Hedeco | 04/05/1983SE |
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Questions and answers
When was Syncor Trich Direct Immunofluorescence Assay cleared by the FDA?
Syncor Trich Direct Immunofluorescence Assay (K852665) received a 510(k) decision of Substantially Equivalent on August 13, 1985, 50 days after the submission was received.
What is the product code of K852665?
The FDA product code is JWZ – Kit, Screening, Trichomonas, a Class I (low risk) device regulated under 21 CFR 866.2660.