510(k) K960491
- Device
- Micro Haematocrit Centrifuge
- Applicant
- HAWKSLEY & SONS LTD.
- 510(k) number
- K960491
- Product code
- CKG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-18
- Date received
- 1996-02-01
- Regulation
- 862.1025
- Classification name
- Radioimmunoassay, Acth
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- J.A. J DINNING
- Address
- Marlborough Rd. Lancing Business Park Lancing, West Sussex GB BN15 8TN BN15 8TN
FDA Registration Numbers#
- 3006198300
- 3002800697
- 2020808
- 3002792284
- 2245285
- 2025099
- 2432235
- 3022178699
- 3007118747
- 9612316
- 2020726
- 1222302
- 1036362
- 8031673
- 3005529799
- 9610126
- 8021924
- 3002806944
- 2032839
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CKG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223867 | IDS ACTH II | Immunodiagnostic Systems Limited | 2023-08-18 |
| K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 | Tosoh Bioscience, Inc. | 2011-12-01 |
| K060585 | ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH | Roche Diagnostics Corp. | 2006-05-03 |
| K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | Scantibodies Laboratory, Inc. | 2005-05-20 |
| K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | Scantibodies Laboratory, Inc. | 2002-06-03 |
| K002638 | FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT | Future Diagnostics B.V. | 2001-01-17 |
| K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | Sangui Biotech, Inc. | 1998-08-19 |
| K962601 | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE | Nichols Institute Diagnostics | 1996-12-24 |
| K960066 | IMMULITE ACTH | Diagnostic Products Corp. | 1996-02-16 |
| K940271 | INCSTAR ACTH IRMA | Incstar Corp. | 1994-08-02 |
| K926396 | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT | Nichols Institute | 1993-07-27 |
| K915727 | ACTH IRMA KIT II MITSUBISHI YUKA | Mitsubishi Yuka America, Inc. | 1992-03-02 |
| K910178 | ACTH IRMA KIT MITSUBISHI YUKA | Science Regulatory Services Intl. | 1991-05-22 |
| K900147 | MODIFIED DSL-2300 ACTH RIA | Diagnostic Systems Laboratories, Inc. | 1990-03-01 |
| K882741 | ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES | Nichols Institute Diagnostics | 1988-08-30 |