510(k) K770850
- Device
- TRAY, BLOOD GAS, ARTERIAL, #4014
- Applicant
- CONCORD LABORATORIES, INC.
- 510(k) number
- K770850
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-15
- Date received
- 1977-05-09
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- 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#
- 3010384323
- 3010934635
- 3016965628
- 3005798905
- 3017494520
- 3000247873
- 3034667025
- 3012944064
- 3004142400
- 3027339877
- 3012410077
- 3015539532
- 3003418325
- 3013764800
- 9614033
- 3015620563
- 1720929
- 3009302820
- 3013188547
- 3002682307
- 1000312731
- 2650089
- 3018125942
- 2027062
- 2517117
- 2032521
- 3015142721
- 3005202235
- 3027500452
- 3004431266
- 3013561817
- 9680222
- 3010197239
- 3010621964
- 3010830834
- 3029960285
- 3009337401
- 1060680
- 3009423112
- 3006498370
- 1019003
- 3007407626
- 8041187
- 3015474594
- 9610847
- 3036679495
- 3013556777
- 1647137
- 9680615
- 1417485
- 3014312726
- 1219205
- 3003589911
- 1211998
- 3029755538
- 3000126234
- 9610993
- 3012116434
- 2029214
- 3030412764
- 3004111573
- 3012798826
- 3008650117
- 3009761558
- 2648666
- 3008307705
- 3004425647
- 3043603327
- 2647898
- 2523676
- 3014456066
- 3033589330
- 3015997711
- 8010803
- 3021393544
- 3006891665
- 3009746425
- 3031788372
- 2024024
- 3020138744
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | 2026-07-13 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026-06-18 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | 2026-06-12 |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | 2026-04-17 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026-02-23 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | 2025-12-12 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth | 2025-08-22 |
| K251350 | BD Plastipak™ Syringe | Becton, Dickinson and Company | 2025-07-29 |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | CMT Health PTE., Ltd. | 2025-07-25 |
Legacy Summary#
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FDA Review#
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