Trichomate(R) Super
FDA 510(k) K875138 · Mercia Diagnostics , Ltd.
510(k) numberK875138
Submission
- Device name
- Trichomate(R) Super
- Applicant
- Mercia Diagnostics , Ltd.
Guildford, Surrey England, GB - Received
- December 15, 1987
- Decision date
- May 13, 1988
- 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 |
| 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 |
| K852665 | Syncor Trich Direct Immunofluorescence AssayJWZ · Traditional | Syncor Intl. Corp. | 08/13/1985SE |
| K830497 | Pem-TJWZ · Traditional | Hedeco | 04/05/1983SE |
More from Hedeco
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|---|---|---|
| K915479 | Captia Cmv-TaLFZ · Traditional | 05/04/1992SE |
| K904524 | Captia(R) Syphilis M, ModificationLIP · Traditional | 12/26/1990SE |
| K900654 | Modified Captia(R) Syphilis-MLIP · Traditional | 03/08/1990SE |
| K900655 | Modified Captia(R) Toxo-MLGD · Traditional | 03/06/1990SE |
| K896295 | Captia(R) Cmv-MLFZ · Traditional | 03/06/1990SE |
| K896194 | Captia(R) Cmv-GLFZ · Traditional | 03/06/1990SE |
| K885300 | Captia(R) Rubella-MLFX · Traditional | 08/15/1989SE |
| K883924 | Captia(R) Rubella-GLFX · Traditional | 08/15/1989SE |
| K892802 | Super DuoJWZ · Traditional | 06/13/1989SE |
| K881425 | Captia(R) Syphilis-GLIP · Traditional | 08/04/1988SE |
Questions and answers
When was Trichomate(R) Super cleared by the FDA?
Trichomate(R) Super (K875138) received a 510(k) decision of Substantially Equivalent on May 13, 1988, 150 days after the submission was received.
What is the product code of K875138?
The FDA product code is JWZ – Kit, Screening, Trichomonas, a Class I (low risk) device regulated under 21 CFR 866.2660.