Atlas FDA

NEPHELOMETRIC SOLID TURBIDITY STANDARD

FDA 510(k) clearance K812220 · decided 1981-08-18

Clearance details

K-number
K812220
Device name
NEPHELOMETRIC SOLID TURBIDITY STANDARD
Applicant
Hyland Therapeutic Div., Travenol Laboratories
Decision
Substantially Equivalent
Date received
1981-08-06
Decision date
1981-08-18
Days to decision
12 days
Clearance type
Traditional
Product code
JIW
Device class
2
Regulation number
862.1150
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Hyland Therapeutic Div.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
WAKO CH50 LINEARITY SET (K973055)Wako Chemicals USA, Inc.1997-09-25
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (K970396)Dade Chemistry Systems, Inc.1997-02-20
FLOW CYTOMETRY FITC/PE COMPENSATION KIT (K910255)Sigma Diagnostics, Inc.1991-04-03
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) (K902575)Diagnostic Products Corp.1990-10-04
ACCUSCAN MICROBEAD STANDARDS (K902294)Sigma Chemical Co.1990-07-03
ACS COLLOID OSMOTIC PRESSURE CALIBRATOR (K892213)Analytical Control Systems, Inc.1989-06-21
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD (K883389)Reagents Applications, Inc.1988-12-14
CALIBRATION KIT (K882220)King Diagnostics, Inc.1988-08-02
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 (K880654)American Research Products Co.1988-06-07
UNIMETER CALIBRATION KIT (K880610)Boehringer Mannheim Corp.1988-03-24
AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER (K854028)Verified Medical Research, Inc.1985-12-02
FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM (K851450)Flow Cytometry Standards Corp.1985-09-16

Recalls involving this device

No recalls on record reference this clearance.