510(k) K962499
- Device
- ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
- Applicant
- BARTELS, INC.
- 510(k) number
- K962499
- Product code
- JZT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-05
- Date received
- 1996-06-26
- Regulation
- 866.4520
- Classification name
- Fluorometer
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- REBECCA D FULLER
- Address
- 2005 NW Sammamish Rd., #107 Issaquah WA US 98027 98027
FDA Registration Numbers#
- 9612316
- 3014100717
- 3009984016
- 3029916095
- 3043088937
- 3012289707
- 3008517993
- 3003561301
- 3007407790
- 3043138885
- 3005847079
- 3027645317
- 3013587414
- 8031673
- 3018771894
- 3005529799
Source Documents#
Other 510(k) Records For Product Code JZT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883349 | QLIA IMMUNOCHEMISTRY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-09-07 |
| K882677 | STAT-20 FLUOROMETER | Weaver Medical | 1988-07-12 |
| K864699 | FLUORESCENCE CONCENTRATION ANALYZER (FCA) | Pandex Laboratories, Inc. | 1986-12-22 |
| K863434 | THE FIAX 5000 FLUOROMETER | Whittaker Bioproducts, Inc. | 1986-10-29 |
| K862674 | PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM | Hybritech, Inc. | 1986-08-15 |
| K852240 | SMS, SCREEN MACHINE SYSTEM | Pandex Laboratories, Inc. | 1985-06-11 |
| K842049 | FLUOROSKAN | Flow Laboratories, Inc. | 1984-12-03 |
| K843356 | FIAX 100 FLUOROMETER | Intl. Diagnostic Technology | 1984-09-17 |
| K834070 | IMMPULSE SYSTEM | Paragon Diagnostics, Inc. | 1984-03-23 |
| K831870 | ALLERGENETICS FLUORO-FAST READER | Axonics, Inc. | 1983-08-12 |
| K800698 | AUTOFLUOR SYSTEM | California Immuno Diagnostic, Inc. | 1980-05-28 |
| K782150 | FLUROMETER, DADE | Dade, Baxter Travenol Diagnostics, Inc. | 1979-02-15 |
| K770662 | VIEWER, FLUOROMETIC, MODEL 721 | Corning Medical & Scientific | 1977-04-15 |
Legacy Summary#
summary
FDA Review#
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