Zeua Mycoplasma
FDA 510(k) K944417 · Zeus Scientific, Inc.
510(k) numberK944417
Submission
- Device name
- Zeua Mycoplasma
- Applicant
- Zeus Scientific, Inc.
Raritan, NJ, US - Received
- September 6, 1994
- Decision date
- August 1, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GRZ – Antisera, Fluorescent, All, Mycoplasma Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3375
- Specialty
- Microbiology
Other 510(k)s with product code GRZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946373 | Mycoplasma Slurry and Mycoplasma Crowntitre Ifa Test SystemGRZ · Traditional | Zeus Scientific, Inc. | 02/07/1996SE |
| K931557 | Fuller Laboratories Mycoplasm Pneumonia Ifa-Igg TestGRZ · Traditional | Fuller Laboratories, Inc. | 03/11/1994SE |
| K861716 | Fiax Test Kit for Mycoplasma Pneumoniae-G AntibodyGRZ · Traditional | Whittaker Bioproducts, Inc. | 08/08/1986SE |
| K840012 | Indirect Fluorescent Antibody MycoGRZ · Traditional | Zeus Technologies | 02/27/1984SE |
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Questions and answers
When was Zeua Mycoplasma cleared by the FDA?
Zeua Mycoplasma (K944417) received a 510(k) decision of Substantially Equivalent on August 1, 1995, 329 days after the submission was received.
What is the product code of K944417?
The FDA product code is GRZ – Antisera, Fluorescent, All, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.