ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P090026/S007 · decided 2013-08-20
Approval details
- PMA number
- P090026
- Supplement
- S007
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- P2psa
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2013-04-12
- Decision date
- 2013-08-20
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- OYA
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Chaska, MN
- Statement
- APPROVAL FOR UPDATING THE LABELING OF UNICEL DX1 INSTRUCTIONS FOR USE, OPERATOR'S GUIDE, REFERENCE MANUAL AND ONBOARD SYSTEM HELP. REQUESTED CHANGES TO THE LABELING INCLUDE CHANGING CURRENT CAUTION STATEMENTS TO WARNING STATEMENTS (TO ENHANCE THESAFETY OF THE OPERATOR, AND REMOVING REDUNDANT CAUTION STATEMENTS), ADDING NEW CAUTION STATEMENTS (NOTES FOR PROCEDURE CLARIFICATION), ADDING NEW WARNING STATEMENTS, CHANGING WARNINGTO CAUTION AND RELOCATING EXISTING WARNING/CAUTION STATEMENTS IN ORDER T
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510(k) clearances by this applicant
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|---|---|---|
| Access BNP II (K252169) | Beckman Coulter, Inc. | 2026-03-24 |
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| Access anti-HAV IgM (K251995) | Beckman Coulter, Inc. | 2026-01-27 |
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| iQ200 Series (K252580) | Beckman Coulter, Inc. | 2025-09-10 |
| Access anti-HAV (K243846) | Beckman Coulter, Inc. | 2025-09-09 |
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