Ipazyme(Tm) Chlamydia True Igm(Tm)
FDA 510(k) K901975 · Savyon Diagnostics , Ltd.
510(k) numberK901975
Submission
- Device name
- Ipazyme(Tm) Chlamydia True Igm(Tm)
- Applicant
- Savyon Diagnostics , Ltd.
Ashdod, IL - Received
- May 1, 1990
- Decision date
- March 8, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKH – Antisera, Immunoperoxidase, Chlamydia Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Specialty
- Microbiology
Other 510(k)s with product code LKH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910644 | Ipazyme (TM) Chlamydia Igg-IgaLKH · Traditional | Savyon Diagnostics , Ltd. | 03/19/1991SE |
| K882674 | Immu-Mark(Tm) Chlamydia Igg/Iga KitLKH · Traditional | Icn Immunobiologicals | 08/15/1989SE |
| K893669 | Cellmatics Shlamydia Detection SystemLKH · Traditional | Difco Laboratories, Inc. | 06/23/1989SE |
| K852869 | Selecticult-ChlamydiaLKH · Traditional | Scott Laboratories, Inc. | 09/19/1985SE |
| K842151 | Chlamydiae Immunoperoxidase Test KitLKH · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 07/20/1984SE |
| K830688 | Combion Skin TestLKH · Traditional | Nicholas H. Maganias | 03/31/1983SE |
| K820390 | Histoset Immunoperoxidase Tissure KitLKH · Traditional | Immulok, Inc. | 04/14/1982SE |
More from Immulok, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921045 | Diaslide Urine Culturing DeviceJXA · Traditional | 09/28/1992SE |
| K914327 | Seroelisa(Tm) Chlamydia Iga Test KitLJC · Traditional | 06/09/1992SE |
| K915281 | Serolisa Chlamydia Igg Test KitLJC · Traditional | 03/23/1992SE |
| K910644 | Ipazyme (TM) Chlamydia Igg-IgaLKH · Traditional | 03/19/1991SE |
Questions and answers
When was Ipazyme(Tm) Chlamydia True Igm(Tm) cleared by the FDA?
Ipazyme(Tm) Chlamydia True Igm(Tm) (K901975) received a 510(k) decision of Substantially Equivalent on March 8, 1991, 311 days after the submission was received.
What is the product code of K901975?
The FDA product code is LKH – Antisera, Immunoperoxidase, Chlamydia Spp., a Class I (low risk) device regulated under 21 CFR 866.3120.