510(k) K895582
- Device
- Qclyte Protein-based Ise Control
- Applicant
- BAXTER HEALTHCARE CORP.
- 510(k) number
- K895582
- Product code
- JJR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-04
- Date received
- 1989-09-15
- Regulation
- 862.1660
- Classification name
- Electrolyte Controls (Assayed And Unassayed)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KRISTA U SMALLEY
- Address
- P.O. Box 25101 Santa Ana CA US 92799 92799
FDA Registration Numbers#
- 3006621318
- 3003917514
- 3005643513
- 3004102403
- 1832216
- 1220972
- 2029372
- 2020715
- 3027645317
- 3003741796
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JJR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990971 | EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 | Medica Corp. | 1999-04-27 |
| K960592 | ELECTROLYTE STANDARDS | Phoenix Diagnostics, Inc. | 1996-05-13 |
| K955630 | RNA MEDICAL HEMAT CONTROL | Bionostics, Inc. | 1996-03-01 |
| K951435 | AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL | Aalto Scientific, Ltd. | 1995-05-02 |
| K943925 | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING | Quantimetrix Corp. | 1994-10-04 |
| K934641 | I-STAT CONTROL LEVELS 1,2,3 | I-Stat Corp. | 1993-12-09 |
| K912513 | ELECTROLYTE CONTROL | Verichem Laboratories, Inc. | 1991-07-19 |
| K902266 | ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) | Phoenix Diagnostics, Inc. | 1990-06-06 |
| K894576 | CIBA CORNING CERTAIN LYTE | Ciba Corning Diagnostics Corp. | 1989-10-30 |
| K881773 | DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET | Casco Standards | 1988-06-10 |
| K881655 | SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL | Biomedical Research & Development Laboratories, Inc. | 1988-05-27 |
| K880710 | PROTEIN BASE ISE CONTROL | Bionostics, Inc. | 1988-03-24 |
| K863333 | AVL ISE-TROL ELECTROLYTE CONTROL | Avl Scientific Corp. | 1986-09-29 |
| K834505 | HUMAN SERUM ELECTROLYTE CONTROL-LIQUID | Quantimetrix Corp. | 1984-04-13 |
| K831389 | STAT-TRAK LIQUID ELECTROLYTE CONTROL | United Diagnostics, Inc. | 1983-08-10 |