Company ยท US
Trinity Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1998. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 8 |
| BSY | Catheters, Suction, Tracheobronchial | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 2 |
| KMF | Bandage, Liquid | 2 |
| LRO | General Surgery Tray | 2 |
| MCZ | Suture Removal Kit | 2 |
| CAZ | Anesthesia Conduction Kit | 1 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| EIA | Unit, Operative Dental | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | 1 |
| FMF | Syringe, Piston | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| FRG | Wrap, Sterilization | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| FXX | Mask, Surgical | 1 |
| GBQ | Catheter, Continuous Irrigation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 1998 | K981441 | HEART CATH TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. | DQO |
| Feb 4, 1998 | K974238 | DENTAL TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. | EIA |
| Dec 12, 1997 | K974286 | CIRCUMCISION TRAY, CAT. NO. 70340 Trinity Laboratories, Inc. | HFX |
| Aug 1, 1997 | K972160 | CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST Trinity Laboratories, Inc. | DCK |
| Mar 31, 1997 | K970722 | EYE TRAY Trinity Laboratories, Inc. | KKX |
| Feb 14, 1997 | K965201 | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. | LRO |
| Jan 22, 1997 | K964921 | BASIC BIOPSY TRAY. DISPOSABLE, STERILE Trinity Laboratories, Inc. | LRO |
| Nov 16, 1995 | K953929 | MID-STREAM COLLECTION SET-STERILE Trinity Laboratories, Inc. | LIO |
| Sep 21, 1995 | K952058 | STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE Trinity Laboratories, Inc. | FOZ |
| Sep 8, 1995 | K953070 | WOUNDFOAM 4 X 4 Trinity Laboratories, Inc. | KMF |
| Jul 3, 1995 | K951506 | SUCTION CATHETER KIT, STERILE, SINGLE-USE Trinity Laboratories, Inc. | BSY |
| Jun 15, 1995 | K951479 | CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE Trinity Laboratories, Inc. | FCM |
| Jun 15, 1995 | K951443 | STANDARD FOLEY SYSTEM PAK Trinity Laboratories, Inc. | FCN |
| Feb 16, 1995 | K945671 | CONTINUOUS EPIDURAL ANESTHESIA TRAY Trinity Laboratories, Inc. | CAZ |
| Aug 5, 1994 | K942221 | IRRIGATION TRAY WITH PISTON SYRINGE Trinity Laboratories, Inc. | FMF |
| Jun 29, 1994 | K941999 | HYPERTONIC SALINE WET DRESSING - STERILE Trinity Laboratories, Inc. | KMF |
| May 27, 1994 | K942014 | STERILE WATER WET DRESSING Trinity Laboratories, Inc. | MGF |
| Mar 10, 1994 | K933526 | STERILE WATER Trinity Laboratories, Inc. | JOL |
| Feb 17, 1994 | K934750 | YANKAUER WITH CONNECTING TUBING Trinity Laboratories, Inc. | GCJ |
| Feb 17, 1994 | K930418 | CRYPTO-LEX SYSTEM Trinity Laboratories, Inc. | GMD |
| Nov 24, 1993 | K934258 | SALINE WET DRESSING- STERILE Trinity Laboratories, Inc. | FRO |
| Oct 1, 1993 | K933412 | SALINE SOLUTION-STERILE Trinity Laboratories, Inc. | JOH |
| Aug 10, 1993 | K926173 | STAPH-A-LEX(TM) SYSTEM Trinity Laboratories, Inc. | JWX |
| Jun 28, 1993 | K923361 | I.V. START KIT, STERILE, DISPOSABLE Trinity Laboratories, Inc. | LRS |
| Mar 3, 1993 | K920346 | VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL Trinity Laboratories, Inc. | KKX |
| Dec 7, 1992 | K915320 | RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST Trinity Laboratories, Inc. | DHR |
| Oct 19, 1992 | K920284 | DRAPE UTILITY/SURGICAL STERILE DISPOSABLE Trinity Laboratories, Inc. | KKX |
| Oct 5, 1992 | K921490 | DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP Trinity Laboratories, Inc. | FRG |
| Sep 21, 1992 | K923098 | STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE Trinity Laboratories, Inc. | BSY |
| Sep 1, 1992 | K920846 | CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER Trinity Laboratories, Inc. | FXX |
| Aug 27, 1992 | K921281 | TRACHEOSTOMY CARE KIT Trinity Laboratories, Inc. | BTO |
| Aug 27, 1992 | K920281 | TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE Trinity Laboratories, Inc. | BTO |
| Aug 17, 1992 | K920518 | E.R. SUTURE TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. | KKX |
| Aug 13, 1992 | K921394 | DRESSING CHANGE TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. | KKX |
| Aug 13, 1992 | K921204 | DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. | KKX |
| Aug 13, 1992 | K921203 | INCISSION & DRAINAGE TRAY Trinity Laboratories, Inc. | KKX |
| Jul 21, 1992 | K922033 | SALINE SOLUTION- STERILE Trinity Laboratories, Inc. | CCQ |
| May 29, 1992 | K920282 | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE Trinity Laboratories, Inc. | NAB |
| May 22, 1992 | K920283 | DISPOSABLE SKIN STAPLE REMOVER Trinity Laboratories, Inc. | MCZ |
| May 11, 1992 | K920517 | MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP Trinity Laboratories, Inc. | KKX |
| May 11, 1992 | K920280 | SUTURE REMOVAL KIT, STERILE, DISPOSABLE Trinity Laboratories, Inc. | MCZ |
| May 5, 1992 | K921464 | CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT Trinity Laboratories, Inc. | GBQ |
| Apr 16, 1992 | K920516 | GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB Trinity Laboratories, Inc. | KDD |
| Jun 28, 1990 | K902541 | MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX Trinity Laboratories, Inc. | KTN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||