510(k) K944417
- Device
- ZEUA MYCOPLASMA
- Applicant
- ZEUS SCIENTIFIC, INC.
- 510(k) number
- K944417
- Product code
- GRZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-08-01
- Date received
- 1994-09-06
- Regulation
- 866.3375
- Classification name
- Antisera, Fluorescent, All, Mycoplasma Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD R TOURVILLE
- Address
- P.O.Box 38 Raritan NJ US 08869 08869
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K946373 | MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM | Zeus Scientific, Inc. | 1996-02-07 |
| K931557 | FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST | Fuller Laboratories, Inc. | 1994-03-11 |
| K861716 | FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY | Whittaker Bioproducts, Inc. | 1986-08-08 |
| K840012 | INDIRECT FLUORESCENT ANTIBODY MYCO | Zeus Technologies | 1984-02-27 |
Legacy Summary#
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FDA Review#
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