510(k) K851253
- Device
- TDX ANALYZER W/NEPHELOMETRY CAROUSEL
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K851253
- Product code
- JQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-04-30
- Date received
- 1985-03-28
- Regulation
- 862.2700
- Classification name
- Nephelometer, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BEVERLY G CHAMBERS
- Address
- 1921 Hurd Dr. P.O.Box 152020 Irving TX US 75015 75015
FDA Registration Numbers#
- 3008517993
- 1119779
- 1111096
- 1924669
- 3009238284
- 3027977508
- 3038188172
- 2050012
- 3006786907
- 3006198300
- 1530126
- 8021914
- 3008862790
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962294 | IMMAGE IMMUNOCHEMISTRY SYSTEM | Beckman Instruments, Inc. | 1996-08-21 |
| K922273 | ARRAY(R) 360 | Beckman Instruments, Inc. | 1992-08-19 |
| K885263 | QMS(TM) - THEOPHYLLINE | Seradyn, Inc. | 1989-03-28 |
| K851234 | A-JUST TURBIDITY METER | Abbott Laboratories | 1985-04-29 |
| K801362 | ALBUMIN NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | 1980-07-21 |
| K801089 | J.T. BAKER NEPHELOMETER | J.T. Baker Chemical Co. | 1980-05-28 |
| K792045 | BIOVATION NEPHELOMETER | Biovation, Inc. | 1979-10-30 |
| K790103 | NEPHELOMETER, MIC-2000 LASER | Dynatech Corp. | 1979-03-12 |
| K781554 | RAD-291 | Organon, Inc. | 1978-10-11 |
| K781644 | ANTIBIOTIC NEPHELOMETER | Biovation, Inc. | 1978-10-03 |
| K780251 | NEPHELOMETER | Kallestad Laboratories, Inc. | 1978-04-06 |
| K772361 | LASER IMMUNONEPHELOMETRIC ANALYZER | G.D. Searle and Co. | 1978-01-30 |
| K771446 | TRANSPORTEO MODULE | Hyland Therapeutic Div., Travenol Laboratories | 1977-08-10 |
Legacy Summary#
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FDA Review#
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