510(k) K801300
- Device
- Dupont 'aca' Conjugated Bilirubin(cbil)
- Applicant
- E.I. DUPONT DE NEMOURS & CO., INC.
- 510(k) number
- K801300
- Product code
- JIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-08
- Date received
- 1980-06-02
- Regulation
- 862.1150
- Classification name
- Calibrator, Surrogate
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3017970519
- 9613959
- 3022099814
- 2517506
- 3007701696
- 3009711478
- 3010421384
- 3011310576
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JIW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973055 | WAKO CH50 LINEARITY SET | Wako Chemicals USA, Inc. | 1997-09-25 |
| K970396 | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR | Dade Chemistry Systems, Inc. | 1997-02-20 |
| K910255 | FLOW CYTOMETRY FITC/PE COMPENSATION KIT | Sigma Diagnostics, Inc. | 1991-04-03 |
| K902575 | SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) | Diagnostic Products Corp. | 1990-10-04 |
| K902294 | ACCUSCAN MICROBEAD STANDARDS | Sigma Chemical Co. | 1990-07-03 |
| K892213 | ACS COLLOID OSMOTIC PRESSURE CALIBRATOR | Analytical Control Systems, Inc. | 1989-06-21 |
| K883389 | RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD | Reagents Applications, Inc. | 1988-12-14 |
| K882220 | CALIBRATION KIT | King Diagnostics, Inc. | 1988-08-02 |
| K880654 | AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 | American Research Products Co. | 1988-06-07 |
| K880610 | UNIMETER CALIBRATION KIT | Boehringer Mannheim Corp. | 1988-03-24 |
| K854028 | AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER | Verified Medical Research, Inc. | 1985-12-02 |
| K851450 | FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM | Flow Cytometry Standards Corp. | 1985-09-16 |
| K852260 | QUICK-CHEM CALIBRATION SET | Seragen Diagnostics, Inc. | 1985-07-22 |
| K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD | Hyland Therapeutic Div., Travenol Laboratories | 1981-08-18 |
| K800304 | CENTRIFICHEM FILTER CALIBRATION SET | Union Carbide Corp. | 1980-03-12 |