510(k) K905226
- Device
- TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL
- Applicant
- ENZYME TECHNOLOGY, INC.
- 510(k) number
- K905226
- Product code
- JGY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-12-11
- Date received
- 1990-11-20
- Regulation
- 862.1705
- Classification name
- Colorimetric Method, Triglycerides
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER KLAMKA
- Address
- 415 Howe Ave. Shelton CT US 06484 06484
FDA Registration Numbers#
- 1181121
- 3012133212
- 2432235
- 3020885868
- 1649661
- 3004146366
- 8040374
- 3015525148
- 3008959428
- 9613069
- 3011061417
- 3002736372
- 3020978007
- 9615507
- 2939693
- 3008517993
- 3010891909
- 2531491
- 1616487
- 3014325803
- 2027969
- 2030633
- 3023162659
- 1423455
- 1219029
- 3021841051
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JGY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120664 | PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM | Abaxis, Inc. | 2012-04-24 |
| K023639 | PICCOLO TRIGLYCERIDES TEST SYSTEM | Abaxis, Inc. | 2003-01-24 |
| K000586 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | Polymer Technology Systems, Inc. | 2000-07-03 |
| K991894 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | Polymer Technology Systems, Inc. | 2000-05-24 |
| K971005 | TRIGLYCERIDES | Derma Media Lab., Inc. | 1997-04-21 |
| K954187 | TRIGLYCERIDES REAGENT | Schiapparelli Biosystems, Inc. | 1995-10-23 |
| K941063 | DNA TRIGLYCERIDE PROCEDURE | Data Medical Associates, Inc. | 1994-07-20 |
| K931116 | IL TEST(TM) TRIGLYCERIDE | Instrumentation Laboratory CO | 1994-03-28 |
| K914033 | CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST | Cholestech Corp. | 1991-09-27 |
| K902202 | DMA TRIGLYCERIDE (GPO) PROCEDURE | Data Medical Associates, Inc. | 1990-07-31 |
| K894063 | TRIGLYCERIDE (GPO) TRINDER REAGENT | Sigma Diagnostics, Inc. | 1989-09-07 |
| K885134 | CLINISTAT TRIGLYCERIDES REAGENT TEST | Heraeus Kulzer, Inc. | 1989-02-10 |
| K860731 | TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) | Trace Scientific , Ltd. | 1986-04-07 |
| K832460 | TRIGLYCERIDE REAGENT-TRINDER-GPO | Seppim, Inc. | 1983-09-12 |
| K821106 | TRIGLYZYME V EIKEN | Syn-Kit, Inc. | 1982-05-05 |
Legacy Summary#
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FDA Review#
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