510(k) K840012
- Device
- INDIRECT FLUORESCENT ANTIBODY MYCO
- Applicant
- ZEUS TECHNOLOGIES
- 510(k) number
- K840012
- Product code
- GRZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-02-27
- Date received
- 1984-01-04
- Regulation
- 866.3375
- Classification name
- Antisera, Fluorescent, All, Mycoplasma Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K944417 | ZEUA MYCOPLASMA | Zeus Scientific, Inc. | 1995-08-01 |
| 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 |
Legacy Summary#
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FDA Review#
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