510(k) K861716
- Device
- FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY
- Applicant
- WHITTAKER BIOPRODUCTS, INC.
- 510(k) number
- K861716
- Product code
- GRZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-08-08
- Date received
- 1986-05-06
- 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#
- Contact
- LOUISE M HARRIS
- Address
- 8830 Brigg Ford Rd. Walkersville MD US 21793 21793
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 |
| K840012 | INDIRECT FLUORESCENT ANTIBODY MYCO | Zeus Technologies | 1984-02-27 |
Legacy Summary#
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FDA Review#
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